Jobs list of Chemical & Quality Assurance / Quality Control

EHS Manager

High level role

9 - 12 million yen Other Chemical Quality Assurance / Quality Control

Company overview: -
Responsibilities: 1. Supports EHS director in planning and executing the activities of the Environmental Health & Safety Department within a supply chain environment, to ensure that environmental health and safety risks are kept to a minimum through effective compliance with EHS policies, procedures and legislation.2. Provides Health, Safety and Environmental training and instruction, assist with the promotion of environmental health & safety policies, procedures & operational practices, to provide advice and assist in environmental health & safety projects within their sphere of competency.3. Provides leadership, expertise, support, and assistance in facility health & safety matters.4. Ensures that operating facilities are in compliance with applicable laws and conforming to the corporate Environmental and Safety Management System (ESMS) requirements. Maintain and develop the ESMS ensuring alignment with current legislation, corporate requirements, and ISO 14001.5. Facilitates a culture of safety consciousness and continuous improvementMajor Duties:May have responsibility for the management of junior EHS staff or individuals in contract positions.
Support the EHS Director in achieving the strategic goals and KPI’s of the EHS department.
Keep abreast of EHS regulations and provide regulatory guidance to the sites regarding new or updated regulatory requirements.
Identify needs in the site’s EHS programs and develop and implement procedures and training programs to ensure compliance. Assist in implementation of the environmental and safety management system in conformance with legal requirements and ISO 14001/ 45001.
Develop and amend site EHS policies and procedures as required by business needs and changing legislation
Lead EHS management system audits and inspections to ensure the site’s compliance with EHS processes, procedures, and legal compliance register. Identify significant exposures and recommend appropriate actions to EHS Director, and senior management as needed, for compliance with local regulations and the company policy.
Lead and ensure appropriate implementation of internal policies, procedures and systems relating to the Environmental, Health & Safety compliance.
Actively prepare sites for EHS regulatory inspections.
Investigate accidents, incidents and near misses. Conduct root cause analysis. Assist in coordinating responses to regulatory agencies with the Legal Department, Global EHS, and other departments as necessary.
Assist in the coordination of EHS-related capital funding and planning.
Work in conjunction with Department Managers to assist in the compilation of Risk Assessments, Safe Systems of Work, policy writing, training and Behavior-Based Safety programs.
Develop and deliver health and safety training to encourage safe working practices. Direct training activities for EHS, including development of EHS training in multiple formats (classroom, online, webinar,etc.) as needed.
Maintain all records – in both paper and electronic format.
Undertake monthly reporting on Key EHS metrics as required at both site and corporate levels.
Provide any EHS support as required at Department / Corporate level meetings including monthly EHS Committee meeting attendance.
Control and administer the onsite fire team and fire marshals, devise a program of fire evacuation drills across the site and carry out the program.
Coordinate Fire Risk Assessments ensuring controls are in place to meet legal requirements as required.
Ensure effective management of hazardous and non-hazardous waste collections from site is in place to meet corporate and legal requirements.
Maintain an awareness of new and existing relevant laws, rules and regulations, and takes actions appropriate to ensure timely compliance and communication to appropriate departments.
Coordinate occupational health, medical surveillance, and ergonomic program partnership initiatives as required.
Provide technical guidance and leadership for the implementation and maintenance of the ISO 14001/ 45001 programs.
Ensure close communication with both APAC and Global EHS communities.

【茨城】品質管理

語学力があり品質管理経験がある方必見です！

7 - 10 million yen Other Chemical Quality Assurance / Quality Control

Company overview: 同社はシリコーン事業を展開しています。
Responsibilities: ＜品質管理保証業務＞品質保証・管理体制の維持・管理・改善
国内製造シリコーン製品の品質検査、品質安定化業務の推進・社内品質安定化会議の主導、検査機器管理（校正・メンテナンス）
社内品質トラブルの対応、原因究明、是正・予防措置の社内対応の主導
顧客での品質クレームの対応、原因究明、是正・予防措置、報告書作成、顧客対応の主導
ドイツ本社、および海外ワッカーグループの品質管理責任者（マネージャー）との定期的な打ち合わせ、情報交換、グローバル共同プロジェクトへの参加（ドイツ本社とのWEB会議：月１回、ワッカーグローバルメンバーとのプロジェクトWEB会議：四半期ごと）等

品質評価スタッフ（食品領域）

Global big cosmetic company

6 - 9.5 million yen Kanagawa Chemical Quality Assurance / Quality Control

Company overview: Our Client is a Japanese multinational personal care company
Responsibilities: 食品OEM監査、製造工程監査。
輸送試験実施。
お客様クレーム対応。
４M（Man,Material,Method,Machine）変更対応

Regional Process Safety Expert / Petrochemicals @110y/o Worldwide Group

APAC Head of Safety, Top Firm

9 - 15 million yen Other Chemical Quality Assurance / Quality Control

Company overview: Our client is a leading manufacturer of industrial gases.
Responsibilities: Technical support related to process safety of gas manufacturing plants
Technical guidance
Process safety improvement activities of gas manufacturing plants
Optimization of equipment maintenance of gas manufacturing plants (considering maintenance of process safety )
Process safety Progress management and reporting of activities

【東京】品質マネジメント

海外も含めた全製造拠点の品質管理体制の強化を担当していただきます。

6 - 10 million yen Tokyo Chemical Quality Assurance / Quality Control

Company overview: Our client is a top Japanese non-ferrous metals manufacturing and recycling company that produces a range of non-ferrous metals. They also have a focus on developing and providing advanced materials for use in electronics, automotive, and other industrial applications.
Responsibilities: 入社後1年程度は、既存メンバーのアシストをしながら業務を覚えて頂きます
製造拠点は約40箇所以上あります。そのうち海外拠点は約15箇所あり、定期的な海外出張が発生します。（月１～２回程度）
全製造拠点に対する内部監査:
監査の準備（監査プログラムの作成、前回監査からの進捗確認等）
監査報告書の作成、次回監査に向けての課題整理（製造拠点と合意した内容が主）
製造拠点との日次・定期の情報交換など
品質管理を支援するITツールの開発:
ご経験のある方は、ツール開発もお任せする予定です
クレーム対応など品質保証業務は、募集職種では想定しておりません。

【東京】品質管理マネジメント

半導体業界で品質管理・保証のご経験がある方、必見です！

8.9 - 11 million yen Tokyo Chemical Quality Assurance / Quality Control

Company overview: Our client is a top Japanese non-ferrous metals manufacturing and recycling company that produces a range of non-ferrous metals. They also have a focus on developing and providing advanced materials for use in electronics, automotive, and other industrial applications.
Responsibilities: 事業部で扱う製品の品質保証業務
業務詳細：
製造委託先で製造される製品について、委託先及び原料メーカーへのサプライヤ品質管理(認定、監査、仕様管理、工程異常・工程変更管理)
顧客への品質保証(クレーム対応、顧客向け品質資料作成、顧客仕様書の作成、顧客監査)
委託先への品質サポート(委託先ルール構築、検査書、QC工程表、FMEA等品質資料の内容確認・指導)

品質保証

成長環境でグローバルに活躍

5 - 8 million yen Saitama Chemical Quality Assurance / Quality Control

Company overview: Our client is a medical device company.
Responsibilities: QMS、ISO13485の事務局
CEマーキング等の維持管理、監査対応
QSR対応、維持管理
安全管理・内部監査
海外顧客の薬事申請の資料とりまとめ

EHS スタッフ

FORTUNE 500 Global Food company

5 - 6.6 million yen Other Chemical Quality Assurance / Quality Control

Company overview: Our client is an American multinational food manufacturing company.
Responsibilities: 労働安全衛生にかかる従業員の安全と健康を守り継続的な改善を図る。公害の防止と自然資源保護(NRC)の管理と継続的な改善を図る。防火、防災にかかる維持管理と継続的な改善を図る。工場の防犯、警備（Security）の管理と強化改善を図る。環境・安全衛生・防災に関連する法令及びその他の要求を管理する。
【主な職務】A) 環境・安全衛生にかかる規則の整備と実践指導B) 健康診断等健康管理にかかる管理と個人情報の取り扱いC) 法的及びその他の要求事項に対応する施策と管理（計画、届出、実践、測定、検証、見直し）D) 事故・災害発生時の対応と改善策E) 自然災害等の対応と対策（備えを含む）F) 各種委員会、センター組織の事務局的活動G) 従業員への教育と啓発活動H) 導入、変更する手順、設備、化学物質等における環境安全衛生に関する指導I) 請負業務者、工事業者、その他場内で活動するものへの安全指導J) 産業医、健診機関との連携とその実践K) 地域団体、周辺住民との環境にかかる渉外L) 防火・防災にかかる訓練と施策M) 防犯・警備にかかる訓練と施策N) その他、特に命を受けた業務O) EHS Centerの事務局として、活動内容の運用について推進する。P) Valueの実践Q) リージョンEHSとの連携を図り、施策を理解し、工場内に展開する。R)責務に関連した外部資格や情報を積極的に取得し、工場に展開することが求められる。

Analytical Lab Manager

High level role

9 - 12 million yen Other Chemical Quality Assurance / Quality Control

Company overview: -
Responsibilities: 【Position Summary & Job Description】Support the QC Lab Lead for a particular shift and/or lab function in planning, organizing, implementing and controlling the daily activities of the QC laboratory to ascertain that raw materials, mass and finished goods meet internal and external specifications. Responsible for overseeing lab testing processes with ability to troubleshoot instruments and issues. Conduct and supervise all OOS investigations and reject investigations. Manage QC lab equipment, qualification protocols and reports, and administration. Participate in continuous improvement projects regionally to drive efficiencies in the lab. Flexible to support off-shift work when needed.
■Management of QC Lab Testing for a shift or lab function (50%)Support the QC Lab Lead for a particular shift and/or lab function in planning, organizing, implementing and controlling the daily activities of the QC laboratory to ascertain that both raw materials and assay of finished goods/mass meet internal and external specification. This includes management for lab workflow, sample analysis, sample retention, standards management, raw material qualification, TPM testing, outsourced testing, inventory management and document management
Ensure execution of data integrity checks / verifications per procedures
Provide QC expertise to plant hygiene program and lead corrective action based on findings
Ensure there is testing support in relation to the environmental monitoring program and any associated risk assessments
Identify SOPs and support QC Lab Lead in work instruction updates or creating new based on lab trends and CAPAs.
Review SOPs and work instructions and provide to QC Lab Lead for approval.
Review and trending of OOS, CAPAs and deviations related to their QC lab function
■Testing Data Review and Release - Data Reviewer role responsibilities (10%)Review of routine supporting test data and results, including sample preparation records, chromatograms / graphs, logbooks, calculations, and data sheets. Enter results in SAP/LIMS.
Release of raw materials, non-OTC mass, and Cosmetic FGs in SAP
Review of non-routine supporting test data and results (i.e. micro testing for water systems, validation testing)
■Equipment Program (10%)Manage QC lab equipment budget, equipment purchases, installation and initiate change control as needed
Development of lab equipment qualification (IQ/OQ/PQ) protocols and reports
Manage specific area’s equipment administration, including calibration, preventive maintenance, and troubleshooting as needed
■Compliance / Continuous Improvement within Lab Function Area (10%)Ensure all lab processes are adhering to relevant regulatory GMPs and global company policies & procedures
Participate in internal audits to ensure regulatory readiness
Work collaboratively with Planning, GBSC, QA Labs, Manufacturing, Validation, and Operations to drive continuous improvement.
Monitor lab KPIs and drive improvements
Ensure all customer complaints are investigated, improvements implemented and response made in a timely manner
■Personnel Management & Training (20%)Apply QC Lab objectives to their lab function area and conduct performance reviews against those objectives.
Provide the coaching, mentorship and training necessary to support ongoing personal and professional development of QC lab staff (GMP and refresher training)
Assist in the development and execution of quality training curriculum for the laboratory

品質保証/薬事

海外売上比率は約7割／成長企業で長く働ける環境

5 - 8 million yen Tokyo Chemical Quality Assurance / Quality Control

Company overview: Our client is a medical device company.
Responsibilities: 日本国内はもとより、欧米、アジアなど世界に製品を輸出している同社で品質保証として業務全体を把握・管理する業務に携わっていただきます。
将来は全体の管理とりまとめをおこなっていただくことを期待します。QMS、ISO13485の事務局
CEマーキング等の維持管理、監査対応
QSR対応、維持管理
安全管理・内部監査
海外顧客の薬事申請の資料とりまとめ
等々の医療機器の品質保証業務を一部から担っていただきます。

ケミカルラボラトリーテスティングリーダー候補（化学物質分析）

化学分析において国内No1の実績を誇るケミカルラボラトリー

5.5 - 8 million yen Kanagawa Chemical Quality Assurance / Quality Control

Company overview: Our Client is an inspection and certification body.
Responsibilities: 化学分析の分析業務 (前処理(酸アルカリ有機溶媒)、ICP, UV/Vis, GC/MS, イオンクロマトなど)
ISO17025 認定施設にて要求される品質管理、技術管理業務
新規サービス(分析項目)の拡大や海外グループとの分析技術の情報交換
SVHC分析の新規設備導入・サービス立ち上げ

Group Manager, Safety Group, Safety, Quality & Sustainability Dept

EHS経験者歓迎！/国内最大手化粧品会社

11 - 21.5 million yen Kanagawa Chemical Quality Assurance / Quality Control

Company overview: Our Client is a Japanese multinational personal care company
Responsibilities: SQS部の安全グループ（Safety Group, Safety, Quality & Sustainability Dept）のグループマネージャーとして、下記グループ業務のマネジメントを行うともに、自らもPlaying Managerとして課題解決にhands－onで取り組む。休業災害ゼロのSupply Network本部ビジョンの達成のため、グローバル安全マネジメントシステムの構築と展開及び監査を実行する。
Supply Network全体における労働安全衛生課題を理解し、国内外の工場やDCと連携をし、現状分析とアクションプランの立案・実行する。

Quality & Food Safety Manager

FORTUNE 500 Global Food company

9 - 10 million yen Other Chemical Quality Assurance / Quality Control

Company overview: Our client is an American multinational food manufacturing company.
Responsibilities: The responsibility of the role is to deliver our agenda, through the implementation, maintenance and administration of all Quality and Food Safety requirements of the factory in line with company policy and statutory compliance.
Develop and implement appropriate plans, programs and activities to achieve objectives set in company policy

Compliance Specialist

High level role

5.5 - 8.5 million yen Other Chemical Quality Assurance / Quality Control

Company overview: Our client is dealing manufacture, sale, import and export of cosmetics.
Responsibilities: Document Specialist is responsible for leading the coordination and management of Quality documentation system readiness to ensure the compliance with the regulatory and corporate requirements by documenting and maintaining all necessary quality policies, procedures, standards, forms, work instructions, guideline and manuals. This includes management of GMP document control systems, periodical document review and audit, document translation to local language where required.
Policies, Procedures and Standards (70%)Document, implement and enforce policies, procedures and standards including translation with local language
Support QA Director and Quality Compliance Manager to shape and maintain Quality Management System
Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices
Understand Global QMS document structure, identify local documentation requirements (where required) to manage local uniqueness, manage document creation and approval process.
Support Quality Training Manager to develop the training strategy and executional plan for core procedures etc to ensure site employees are fully trained against to the approved procedures.
Document Control Systems (30%)Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems
Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.

HSE Manager

6 - 13 million yen Kansai Chemical Quality Assurance / Quality Control

Company overview: Our client is a leading manufacturer of industrial gases.
Responsibilities: 安全・品質システムの確立/維持/管理
トラブル発生時の安全/品質面での対応
パトロールと指導
顧客要求事項（監査や安全、品質マネジメントシステム）への対応
社内ドキュメントの更新管理（マネジメントシステム）
設備管理上の品質維持
コンプライアンス含む安全品質活動全般

M&R Assistant Manager

High level role

6 - 8 million yen Other Chemical Quality Assurance / Quality Control

Company overview: -
Responsibilities: 1) Maintenance & Reliability ManagementSupport on building a high-performance M&R organization, creating and supporting a workplace environment that encourages teamwork, empowerment, continuous improvement and robust problem-solving capabilities delivering best in class performance across metrics
As Operation support function, lead operational excellence and every day great execution (EDGE) across M&R, facilities, compounding, and fill and assembly, safely efficiently and effectively managing and executing tooling stores, service, maintenance, and inventory management activity and executing and continuously improving the total productive maintenance program in support of operational, efficiency, quality, and safety.
Ensure reduction of asset down time and improve uptime as a priority. Analyze the cause of downtime and arrive at a solution cooperating with Mechanics and Electricians.
Support the own functions to have a capability of,
- evaluating component reliability and pricing to drive cost savings with no impact to equipment performance- maintaining inventory levels to spares based on failure rates, lead-time, and cost and evaluating other vendors and manufacturers to drive cost saving opportunities- reviewing the new machinery prior to purchase, trials, and validations- Ensure support functions(Tool crib and wash room) get performance on a Right First Time Basis with the prioritization.Interface with the operation’s functions in ensuring customer expectations and KPIs are managed.
Define and develop required communication and rollout plan for addressing asset reliability deficiencies.
Direct implementation and execution of the Continuous improvement process to achieve and deliver Continuous Improvement methodologies.
Partner with Operations and CI to drive Lean and Continuous Improvement processes and ensure all timeline are achieved.
Participate and/or lead M&R Community of Practices across a region and globe for Maintenance and Reliability.
2. Leadership ActivitiesLead and manage some M&R Operation support functions in accordance with established corporate & local management policies, procedures and objectives.
Develop and drive positive cultural change in M&R operations via clear performance improvement plans and confident leadership.
Lead team to successfully execute operations strategies, tactics and annual plans.
Support M&R management on development and training M & R and M&R associated functions including self-directed work team personnel
Provide effective Training and Skill develop programs that will drive and improve productivity and flexibility in cross training.
Deliver sustainable cultural and behavioral changes across the business to build the right relationship between TPM within a CI Lean culture.
Ability to lead, coach, mentor and influence employees and business partners alike.
3. Health & SafetyEnsure compliance with applicable government and local laws, as well as, EGMP, OSHA, EPA, FDA, ISO 9001 and ISO 14002 requirements
Ensure compliance with all statutory and corporate EHS policies (eg. PPE, WHIMS, GMP, ISO 140001, etc.)
Create and Drive a ZERO loss Safety Culture through driving best in class safety initiatives

Compliance Specialist

High level role

5.5 - 8.5 million yen Other Chemical Quality Assurance / Quality Control

Company overview: -
Responsibilities: Document Specialist is responsible for leading the coordination and management of Quality documentation system readiness to ensure the compliance with the regulatory and corporate requirements by documenting and maintaining all necessary quality policies, procedures, standards, forms, work instructions, guideline and manuals. This includes management of GMP document control systems, periodical document review and audit, document translation to local language where required.
Policies, Procedures and Standards (70%)Document, implement and enforce policies, procedures and standards including translation with local language
Support QA Director and Quality Compliance Manager to shape and maintain Quality Management System
Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices
Understand Global QMS document structure, identify local documentation requirements (where required) to manage local uniqueness, manage document creation and approval process.
Support Quality Training Manager to develop the training strategy and executional plan for core procedures etc to ensure site employees are fully trained against to the approved procedures.

Document Control Systems (30%)Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems
Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.

【尼崎】品質管理スタッフ

品質管理・保証の経験がある方必見です！

6 - 8 million yen Kansai Chemical Quality Assurance / Quality Control

Company overview: Our client is researches and develops, manufactures and sells chemicals for electronic substrates.
Responsibilities: 化学薬品工場で、製品品質向上や、製造工程の維持改善など、製造・設計へ指示等を行う品質管理業務を担当いただきます。将来的には、品質管理グループ組織のマネジメントも期待しております。
業務詳細：
製品検査、指導育成等の品質管理や工程管理
不具合の原因解析やその再発防止策の検討
初期流動や変更/変動等の管理および処置検討
計測機器の管理
製品の信頼性試験等の製品評価など

ファシィリティマネージャー（工場施設管理マネージャー）

High level role

6 - 10 million yen Other Chemical Quality Assurance / Quality Control

Company overview: -
Responsibilities: 生産ユーティリティ設備の保守保全に関わる管理業務全般。
新しい機器の導入及び導入後の安定化や各種記録・報告方法の整備と改善
ファシリティ・マネジメント・コントラクターと協力して、生産ユーティリティのコンディションを最良の状態に保ち、常に安定した工場操業ができるようにバックアップする。
生産ユーティリティの安定供給により工場稼働率を向上させる。
工場の生産スケジュールに合わせた点検スケジュールを計画する。
不具合発生時は迅速な対応を取り工場操業への影響を最小にする。
予知保全により設備の更新寿命を延ばす。
省エネルギー運転などを通じて、運転コストの削減に貢献する。
生産廃棄物の保管、搬出、処理手配。
公害の防止と排出基準値の遵守。
年間のKey Performance Indicators (KPI)を設定し、進捗を定期的に報告する。
生産ユーティリティ設備の運転コストとファシリティ・マネジメント・コントラクターの予算管理。
Job Description工場へ常駐し日々の設備巡回点検により生産ユーティリティ設備を総合管理する。
生産ユーティリティを24時間365日、安定に供給する。
ファシリティ・マネジメント・コントラクターを管理して運転・保守・保全業務を遂行する。
常に安全に気を配り、事故や災害を未然に防止する。
常にオペレーションチームとコミュニケーションを取り、生産スケジュールに影響を与えないよう計画する。
法定点検、自主点検のスケジュールを確立し、生産ユーティリティ設備を常に最良の状態に維持する。
不具合発生時はファシリティ・マネジメント・コントラクターを指揮して問題を解決し、迅速に復旧させる。
運転計画、保守保全計画、標準操作手順書を作成する。
生産ユーティリティ設備管理の年度予算を作成し、予算内で業務を実行する。
設備機器更新提案書を作成し、タイミングよく機器を更新する。
法規で定められた有資格者が運転に携わっていることを確認し、有資格者を管理する。
導入済みのBMS・EMS・PMSによるデータを活用し、予知保全に役立てる。
導入後は、資産の管理、モニタリング、予知保全を通じて行う。
機器の定期メンテナンスの実施・監視に基づく予知保全により、生産ユーティリティ設備の更新寿命を延ばす。
排出基準値を理解し、常に正常値内で運転を継続し、周辺環境の維持と公害防止に努める。
各種エネルギーの使用量を毎日記録し、月末に報告書を作成する。
日常点検記録を維持し、必要に応じて報告を行う。
異常発生時には必要な部門、消防、労働基準局、市役所などへ連絡・通報する。
点検作業報告書を作成する。
法規・基準で求められる報告書を作成し、関係官庁へ提出する。
不具合報告書を作成する。
LEED・WELL・FM規格要求による定時点検を実施する。
空調機の分解洗浄を実施する。
エンジンやサテライトなどのオーバーホールを計画し、専門業者へ発注する。
専門点検業者への部分的な委託を立案し発注する。
LNG・洗浄剤の出荷納期を調整しタイムリーな受け入れを実現する。
ケミカル類・油脂類・燃料油類・工業ガス類の購入と補充を管理する。
消耗品・交換部品の購入と交換を管理する。
バッテリーの更新を実施する。
小規模な改修工事を計画実行する。
省エネルギー達成に向けての改善提案を提出する。
施設長寿命化計画およびライフサイクルコストの低減を提案する。
持続可能な社会に向けてGHG排出量の削減を実現する。
水の再循環率の向上を実現する。
河川放流水量の削減を実現する。
生産廃棄物の再利用を検討し、廃棄物の削減を実現する。
必要に応じてグローバルチームと連絡を取り、情報を交換する。

Quality Operations Specialist (F&A)

High level role

5.5 - 8.5 million yen Other Chemical Quality Assurance / Quality Control

Company overview: Our client is dealing manufacture, sale, import and export of cosmetics.
Responsibilities: Position SummaryTo identify, design and lead/execute QE projects through the use of statistical tools and other problem-solving methodologies. This position will drive improvement initiatives locally to ensure that processes are capable of meeting the quality standards and expectations of the Companies and its customers.
To provide technical support to QA and other departments. This position must have technical credibility within the organization as well as with customers and suppliers. This position assures compliance to regulatory requirements and focuses on the consumer expectations.
Job Description & Major Duties:Issues Resolution/Continuous Improvement (60%):Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities
Certify CAPA completion and effectiveness
Escalate critical issues to Quality/Operations leadership as required
Investigate critical customer and consumer complaints
Disposition out-of-spec materials, as directed
Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME
Document Review & Auditing (30%):Conduct documentation reviews in the plant (production, importation and compounding as applicable) for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus the requirements and needs
Perform final (for importation yearly) review of executed batch and filling records and disposition product
Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports.
Participate in routine GMP audits in the plant
Training/Coaching (10%)Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis

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