cGMP Document Control and Records Management

Job Description

Job Description

NOW HIRING! cGMP DOCUMENT CONTROL AND RECORDS MANAGEMENT SPECIALIST

We are seeking a highly organized and detail-oriented Quality Assurance Document Specialist with experience in the biotechnology and pharmaceutical industries to join a dynamic team at our state-of-the-art facility in Norwood, MA. In this role, you will be responsible for maintaining documents in compliance with business needs and regulatory expectations, as well as supporting process improvements in document control and records management.

The ideal candidate will manage the formatting and administration of paper-based and electronic document workflows, oversee the chain of custody, and handle the issuance and archival of paper records. Excellent organizational skills, the ability to work independently on multiple tasks, and the agility to thrive in a fast-paced environment are required.

Location : Norwood, MA (Fully onsite)

Shift : Monday to Friday, 9:00 AM – 5:00 PM

Pay Rate : $69 - $71/hour Key

Responsibilities

• Support cross-functional teams in processing document requests, approvals, and archival workflows.
• Issue and reconcile paper records, including batch records, logbooks, and protocols.
• Manage the archival of all GMP documentation both on-site and off-site, including the organization and maintenance of the on-site archival room.
• Develop and implement process improvements for Document Control and Records Management, including optimizing document types, lifecycles, and workflows within the eDMS.
• Partner with teams to identify efficiencies around the maintenance and control of paper-based documents.
• Provide robust document control and records management support during internal and external audits and inspections.
• Follow all relevant GxP regulations, guidelines, and internal policies. Execute tasks precisely as defined in standard operating procedures (SOPs) and work instructions.
• Strict adherence to Good Documentation Practices (GDP) and Data Integrity requirements to ensure records are complete, maintained, and audit-ready.
• Ability to lift and move document boxes weighing up to 50 lbs as needed.

Qualifications & Requirements

• BS or MS degree, preferably in Sciences or Engineering.
  • 3–5 years of Quality Assurance experience in the pharmaceutical/biotech industry with a BS degree, OR 2+ years of experience with an MS degree.
• Strong QA documentation experience within a pharma or biotech setting is required.
• Demonstrated aptitude or ability to learn and maintain a strong understanding of GxP regulations (including GMP, GLP, GCP, GVP, or other applicable standards).
• Commitment to completing training in assigned learning plans according to defined timelines and requalification cadences
• LIMS experience (i.e.: VEEVA).

TO APPLY: Email Resume to: [email protected]

If this job is not for you, feel free to refer a friend.

Skills

• cGMP
• Document control
• Pharmaceutical
• Biotech
• biotechnology
• LIMS
• Veeva
• GMP
• GxP
• Quality Control
• Quality Assurance
• document management
• data verification
• stability studies
• stability testing
• technical writting
• QC
• document specialist
• QA document control
• records management
• quality systems
• pharma
• life sciences
• SOP
• GDP
• eDMS
• pharma document control

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.