QC Document Control

Job Summary:

The Manufacturing Quality Control Document Control is responsible for managing and maintaining all controlled documentation related to quality, manufacturing processes, and regulatory compliance. This role ensures that documentation is accurate, current, and compliant with internal policies, industry standards, and regulatory requirements. The position supports quality audits, change control processes, and the distribution and retrieval of quality records.

Key Responsibilities:

- Maintain and control quality documentation such as SOPs, work instructions, batch records, specifications, and inspection reports.

- Ensure documents are reviewed, approved, distributed, and archived in accordance with internal procedures.

- Manage document lifecycle through document control systems (electronic or manual).

- Assist in the preparation and coordination of internal and external audits by providing required documentation.

- Track changes and maintain version control to prevent unauthorized revisions.

- Ensure timely routing and approval of document changes and new document requests.

- Support the Quality Control and Manufacturing teams in generating and updating quality records.

- Assist with training coordination related to new or revised quality documents.

- Monitor document compliance to ensure alignment with ISO, GMP, FDA, or other relevant regulations.

- Provide document control metrics and reports to management as needed.

Qualifications:

- Education: High school diploma or equivalent required; Associate’s or Bachelor’s degree in a related field preferred.

- Experience:

- 2+ years in document control or quality-related role in a manufacturing or regulated industry (e.g., pharma, medical devices, food, automotive, aerospace).

- Familiarity with quality systems such as M2M, GMP, FDA, or other regulatory requirements.

- Skills & Abilities:

- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

- Experience with Document Management Systems (eDMS) is a plus.

- Strong attention to detail and organizational skills.

- Excellent communication and teamwork abilities.

- Ability to prioritize and manage multiple tasks in a fast-paced environment.

Working Conditions:

- Office environment within a manufacturing or laboratory facility.

- May require occasional interaction on the production floor with appropriate P

- PE.