Document Control Specialist - Drug Product Ops

Job Description

Job Description

We’re Hiring: Document Control Specialist (Drug Product Operations) 

Are you passionate about precision, life-changing medicine, and ensuring highest-quality standards in modern biotech? Randstad is looking for a driven Document Control Specialist to join our client's Internal Drug Product Manufacturing team at their state-of-the-art facility in Norwood, MA!

In this key role, you will report directly to the Director, Drug Product Operations, partnering closely with Operations and Quality to keep manufacturing records accurate, compliant, and moving forward smoothly.

What We’re Looking For

• Education: Associate’s or Bachelor’s degree in a scientific field, OR a High School Diploma with equivalent experience.

• Experience: 2–4 years in a GMP manufacturing or life sciences environment preferred. (entry-level candidates ready to learn are welcome to apply—we will train!)

• Key Skills: Familiarity with cGMP, GDP, batch records, and logbooks. Experience with electronic batch records (eBR/MES) and drug product or aseptic manufacturing is a huge plus!

Why Join Us? You will play a vital role in ensuring seamless, compliant operations that deliver innovative treatments to patients globally.

Ready to make an impact? Apply today!

salary: $45 - $49.21 per hour
shift: First
work hours: 8 AM - 4 PM
education: High School

Responsibilities

•  Review and approve paper and electronic batch records, attachments, logbooks, forms, protocols, and other manufacturing documentation.
•  Ensure records meet cGMP, GDP, completeness, accuracy, and traceability requirements.
•  Partner with Operations, Quality and cross-functional teams to coordinate corrections, triage, and timely record completion through final Quality approval.
•  Verify all required system transactions are completed and accurate prior to manufacturing record approval, ensuring alignment between executed activities, system records, and supporting documentation.
•  Confirm all required sampling activities, sampling plans, and sample results are completed, reviewed, approved, and closed prior to record approval.
•  Audit manufacturing logbooks and coordinate corrections, issuance, reconciliation, and availability within manufacturing areas.
•  Ensure completed manufacturing documentation is reconciled and transferred for archival.
•  Maintain visibility of documentation status and proactively follow up to meet established approval timelines.
•  Monitor applicable building and facility alarms in accordance with established procedures and assessed in a timely manner.
•  Escalate critical alarms, ensure timely completion and approval of impact assessments, and reconcile and archive all associated documentation.

Skills

• documentation
• document management

Qualifications
• Years of experience: 3 years
• Experience level: Entry Level

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 View email address on us.fitly.work.
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.