- Serves as document control administrator from product development through finished production of dietary supplements and health & wellness products.
- Manage and administer effective document control systems.
- Supports review, update, filing and distribution of controlled documents, including but not limited to Request for Quotes, Formula Specifications, Packaging Specifications, and Component Technical Documents.
- Ensures controlled documents conform with applicable procedures and are maintained to latest revisions, and reviews formats for consistency.
- Creates and maintains filing systems (electronic and paper) for all controlled documents.
- Works with the Operations Manager to establish and execute document control procedures.
- Supports the creation and updates of Standard Operating Procedures (SOPs) related to document control/document management.
- Updates current or future project management systems accordingly.
- Performs proofreading, editing, word processing, and filing support.
- Provides cross-functional support as needed.
- Other duties as needed/assigned.
- Knowledge of cGMP regulations and industry standard guidelines for electronic records.
- Experience with 21 CFR (Part 111 is preferred.)
- 3+ years' experience in managing a cGMP document system.
- Experience in document control, change control, and quality systems.
- Strong technical computer skills using various computer programs and web-based applications, including Microsoft and Google Suite.
- Ability to work under pressure with tight deadlines.
- Able to maintain confidentiality and work with sensitive documents.
- Interact well with colleagues, leadership, and vendors.
- Strong organizational skills.
- Adapts to changing priorities effectively.
- Ability to work independently on assignments.
- Strong problem-solving skills.
- Team player committed to quality.
- Organized and detail oriented.
- Excellent written and oral communication skills
- Ability to manage multiple projects at one time.
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Document Control Specialist - Los Angeles, United States - SPORTS RESEARCH CORPORATION
Description
Job Description
Job DescriptionWe have an opportunity for an experienced cGMP dietary supplement product development Document Control Specialist to join our amazing team here in our beautiful San Pedro, CA office (work from home Thursdays). This role is responsible for ensuring the document control system is managed in compliance with Standard Operating Procedures (SOPs), Quality Systems and complies with our internal procedures, cGMPs, and 21 CFR FDA regulatory requirements. This ensures traceability from product development through finished product production.
Responsibilities Include, But Are Not Limited To:
Skills and Qualifications:
Pay Grade: $ $29.00 Per Hour Depending on Experience
* Sports Research is an equal opportunity employer committed to providing a diverse environment.
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