QA Document Control Specialist

Document Control Specialist

The Document Control Specialist ensures compliance with company and regulatory quality standards for drug and dietary supplement product manufacturing. Knowledgeable of industry and governmental quality regulations.

Key Responsibilities

• Perform Quality Assurance review and approval of executed batch manufacturing and packaging records.
• Formally print, control, and issue official Batch Production Records (BPRs) and labels to the production floor based on the approved Master Manufacturing Records (MMRs). Performing functions necessary to ensure that all relevant manufacturing records are compiled, reviewed, and completed in a compliant, efficient manner, and ultimately determines and documents the final disposition of each batch on the controlled batch records and in the computer system.
• Assist QA management by pre-screening executed batch production folders, verifying that all pages, signatures, dates, and mandatory equipment logs are present and accounted for.
• Processes/Creates quality system documentation for review, approval, distribution, and archival.
• Maintain and secure the physical documentation vault and electronic document management systems to protect data integrity, prevent unauthorized changes, and ensure quick retrieval during regulatory audits. Maintain printed and electronic master files for all quality system documentation.
• Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
• Complies with all quality system policies and procedures.
• Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with Standard Operating Procedures (SOPs) and policies.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs.
• Review SOPs and documents from other departments and provide feedback, as necessary.
• Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
• Assist with training of new employees.
• Coordinate and perform any additional activities or projects assigned by QA Management

Education and Experience

• High School Diploma or GED required; associate or bachelor's degree in a science-related or administrative discipline preferred.
• 1–3 years of document control or quality assurance experience, ideally working in a cGMP-regulated environment (Dietary Supplements, Food Manufacturing, Cosmetics, or Medical Devices).
• Experience with Microsoft Word and Excel required.
• Prior exposure to inventory tracking software (like SAP) or an electronic Document Management System (eDMS) is a distinct plus.
• Equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained.

Knowledge, Skills and Abilities

• Basic knowledge and understanding of current Good Manufacturing Practices (cGMPs), and other regulatory requirements/ guidelines, especially as they relate to nutraceuticals.
• Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}),
• This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as regulatory requirements.
• Must have the ability to handle multiple priorities, maintain confidentiality and interface with individuals from other departments,
• Able to work in fast-paced manufacturing facility with shifting priorities, and flexibility to support manufacturing needs.
• Ability to establish sound positive working relationships and interact with different types of people on all levels of skill, background and position are essential.
• Excellent verbal and written communication skills,
• Extreme focus on detail with the ability to spot typographical errors, data blanks, or discrepancies in records.
• Proficiency in English usage, spelling, grammar and punctuation.
• Must be flexible to work overtime as needed with little to no advanced notice.

Physical/Work Environment/Expectations

• This position works within a GMP Manufacturing Environment, office environment, and inside the plant.
• Must be able to work in controlled environments requiring special gowning.
• Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, hands, and arms.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
• Pace may be fast and job completion demands may be high.
• While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear. The employee must occasionally lift or move up to 20 pounds. Specific vision abilities required by this job include close vision.

Note: This job description is not totally inclusive nor is it designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.