Domaine: Opérations

Type d‘emploi: Temps plein

Ville: New Jersey - Piscataway

Pays: USA

Position Overview: The Manager, Industrial Quality Document Controller collects, maintains and distributes all technical information within industrial quality necessary to define product configuration and control manufacturing processes that ensure conformance to customer requirements; develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center; manages the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.

 Key Responsibilities:

  • Perform frequent audits of master data in SAP for accuracy.
  • Oversee Quality Master Data, performance, reporting and updates.
  • Manage Document Control as well as Records Management and Processes.
  • Enter computer data into plant SAP information system (BOM’s, MFP specifications for QA).
  • Monitors status of raw materials in DGO database.
  • Responsible for formula movement in the DGO database.
  • Maintains specifications throughout the quality system.
  • Responsible for distribution of quality information throughout the plant.
  • Manage release of finished goods through Lot Dossier & OTC batch record review and maintains proper documentation for OTC Product.
  • Prepares Certificates of Analysis for Finished Goods/RM/bulk as requested.
  • Track and manage launch approvals.
  • Troubleshoots release delays, and follow up on aged inventory.
  • Assist Department Managers to develop plan, train document coordinators, revise and maintain procedures.
  • Assist to author, change and update Quality Manual and QA procedures as applicable.
  • Maintains on-line documentation (eQCM).
  • Ensure effective interactions at a departmental level to efficiently incorporate departmental activities into overall company strategies and quality systems.
  • Perform Annual Product reviews.
  • Participate & assist during FDA inspections, Notified Body, and other third party Quality System evaluations. (FDA, ISO9001, ISO 22716, DGO, etc…)
  • Assist to provide training on QM system process, including general Quality System and GMP training.
  • Lead and participate in Performance Improvement projects.

 Educational or Certification Requirements:

  • Bachelor’s degree in engineering or related field is required.

 Previous Experience:

  • At least 5 years prior experience in a cGMP manufacturing environment within Industrial Quality.

 Essential Requirements:

  • Must be able to anticipate needs and work proactively.
  • Must be extremely organized, detailed oriented, and be able to work without supervision.
  • Must have working knowledge of computers with SAP, and Microsoft office skills using Outlook, Work, Excel, Power Point, and Front Page.
  • Ability to multi-task many projects simultaneously.

We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.