About this opportunity
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
In this role you will perform Quality Document Control and Product Release activities within a complex parenteral manufacturing facility, including Batch Record Review and Product Release, Batch Record Issuance, Document Control/Archival, and related investigations/CAPAs and Training. The position collaborates with other QA personnel, Quality Control, Operations, Clients, and Suppliers to establish and maintain requirements for product release and document management. Responsible for ensuring that all products manufactured and/or supported meet established specifications and regulatory requirements.
Responsibilities include but are not limited to:
Perform thorough, quality review of completed Batch Manufacturing Records (MPCRs) and associated executed cGMP documents for commercial drug product lots in accordance with site SOPs and applicable regulatory requirements.
Evaluate completed batch records for accuracy, completeness, legibility, proper documentation practices (GDP), and compliance with approved manufacturing instructions, in-process specifications, and acceptance criteria.
Identify, document, and communicate errors, omissions, and discrepancies found during batch record review, working directly with Manufacturing personnel and frontline supervisors to initiate timely and appropriate corrections in compliance with GDP requirements.
Initiate or support the initiation of deviations and investigations in the eQMS for batch record discrepancies that cannot be corrected via standard GDP correction practices, ensuring proper escalation and documentation.
Collaborate with the Batch Record Review team and Manufacturing to drive continuous improvement in documentation quality, reducing recurring errors through targeted feedback, trend analysis, and retraining recommendations.
Track and report batch record review cycle times to support on-time lot disposition and maintain alignment with established release timelines.
Maintain working knowledge of the product-specific manufacturing processes, equipment, and in-process controls associated with all commercial products manufactured at the site to support effective and knowledgeable batch record review.
Who You Are:
Minimum Qualifications:
High School Diploma or GED.
2+ years of quality assurance experience within GMP regulated environment.
Preferred Qualifications:
Bachelor’s Degree.
Knowledge of product-specific manufacturing processes, equipment, and in-process controls associated with commercial/clinical products manufactured to support effective and knowledgeable batch record review preferred
Ability to operate with a high level of autonomy and collaborate effectively with others.
Essential knowledge of cGMPs.
Strong oral and written communication skills, including internal and external interface.
Ability to train and qualify others in pharmaceutical manufacturing quality activities.
Strategic perspective with self-motivation, resilience, team orientation, and results-driven approach.
Pay Range for this position: $69,200 - $110,900 / year
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here .
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1008 comparable Quality roles across 131 biopharma companies.
Salary context
192 of 1008 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1008 comparable roles
+ 42 more countries
Seniority mix
498 of 1008 peers have a known seniority level
Therapeutic area mix
2 of 1008 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.