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Contract Qa Batch Record Review Jobs (NOW HIRING)

PCI Pharma Services

Qa Specialist Ii - Ops

Bedford, NH · On-site

Quality Assurance Reporting To: QA Manager / QA Director Responsible For (Staff): No The QA ... Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality ...

Eisai, Inc.

QA Specialist (Hybrid)

Raleigh, NC · On-site

$66K - $86K/yr

This role contributes to batch record review, documentation management, investigation support, and ... The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners ...

Eisai

QA Specialist (Hybrid)

Raleigh, NC · On-site

$66K - $86K/yr

This role contributes to batch record review, documentation management, investigation support, and ... The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners ...

Actalent

Quality Assurance Technician

Cambridge, MA

$30 - $40/hr

Review batch records thoroughly and ensure a complete and accurate chain of custody for all ... Job Type & Location This is a Contract position based out of Cambridge, MA. Pay and Benefits The ...

Actalent

Quality Assurance Technician

Cambridge, MA

$30 - $40/hr

Review batch records thoroughly and ensure a complete and accurate chain of custody for all ... Job Type & Location This is a Contract position based out of Cambridge, MA. Pay and Benefits The ...

Eisai

QA Specialist (Hybrid)

Raleigh, NC · Hybrid

$66K - $86K/yr

This role contributes to batch record review, documentation management, investigation support, and ... The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners ...

GL Staffing Services, Inc.

Quality Assurance

Boca Raton, FL · On-site

$75K - $95K/yr

The In-Process Quality Assurance (IPQA) Specialist is responsible for providing real-time quality ... Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) and support ...

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Contract Qa Batch Record Review information

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How much do contract qa batch record review jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for contract qa batch record review in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What are some common challenges faced in a contract QA batch record review role, and how can they be managed?

In a Contract QA Batch Record Review position, one of the most common challenges is managing tight deadlines while ensuring meticulous attention to detail. Batch records often contain complex information, and discrepancies or omissions must be identified and addressed promptly to maintain compliance with regulatory standards. Effective communication with production and quality teams is crucial for resolving issues quickly. Staying organized, prioritizing tasks, and maintaining up-to-date knowledge of relevant regulations can help streamline the review process and minimize errors.

What are the key skills and qualifications needed to thrive as a contract QA batch record reviewer, and why are they important?

To thrive as a Contract QA Batch Record Reviewer, you need a solid understanding of GMP regulations, pharmaceutical manufacturing processes, and experience with batch record documentation, often supported by a degree in life sciences or a related field. Familiarity with quality management systems (QMS), electronic batch record (EBR) systems, and regulatory compliance tools is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for identifying discrepancies and ensuring compliance. These competencies are vital for maintaining product quality, regulatory adherence, and minimizing production risks in pharmaceutical environments.

What is the difference between Contract Qa Batch Record Review vs Contract Quality Assurance Specialist?

AspectContract Qa Batch Record ReviewContract Quality Assurance Specialist
CertificationsGMP, GDP, ISO training, QA certificationsGMP, GDP, ISO training, QA certifications
Work EnvironmentPharmaceutical/biotech manufacturing, quality control labsPharmaceutical/biotech manufacturing, quality assurance departments
Primary ResponsibilitiesReviewing batch records for compliance, documentation accuracyOverseeing quality systems, audits, process validation

The Contract Qa Batch Record Review focuses specifically on reviewing batch documentation for compliance and accuracy during manufacturing. In contrast, the Contract Quality Assurance Specialist has broader responsibilities, including overseeing quality systems and conducting audits. Both roles require GMP knowledge and work within pharmaceutical or biotech environments, but the Batch Record Review is more task-specific, while the QA Specialist has a wider scope of quality management.

What is a contract QA batch record reviewer?

A Contract QA Batch Record Reviewer is a quality assurance professional who is hired on a contract basis to review and verify manufacturing batch records in industries like pharmaceuticals, biotechnology, or food production. Their main responsibility is to ensure that all production documentation complies with regulatory standards and company protocols before products are released. This role involves checking for accuracy, completeness, and consistency in records, identifying any discrepancies or deviations, and working with production teams to resolve issues. Contract-based reviewers may work with multiple clients and help ensure that all batches meet strict quality and safety requirements.
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Contract Qa Batch Record Review jobs near you
Infographic showing various Contract Qa Batch Record Review job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, and 4% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.

Manager, Quality Assurance

Rhythm Pharmaceuticals

Boston, MA • On-site

$110K - $165K/yr

Full-time

Re-posted 23 days ago

Job description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is looking for a Manager Quality Assurance (QA) to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical products. This is an individual contributor management-level role within a CDMO dependent Quality organization. It requires solid technical expertise in sterile pharmaceutical manufacturing, strong CDMO relationship management skills, and fluency in the regulatory expectations for clinical-stage parenteral products. The successful candidate will operate with a high degree of autonomy and will partner closely with CMC development, Regulatory Affairs, Clinical Supply Chain, and CDMO Quality and manufacturing teams. The Manager QA will report to the Director, CMC QA, based in The United States, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties
  • Serve as the quality contact for external manufacturing partners producing sterile drug products, establishing and maintaining quality oversight of clinical manufacturing activities.
  • Manages clinical lot disposition for sterile drug product, including review of batch records, analytical results, and compliance with Regulatory Dossiers.
  • Responsible for the review and approval of process validation documents, protocols and reports, Master Batch Records and Executed Batch Records at the Contract Development and Manufacturing Organization (CDMO).
  • Provides QA oversight during technology transfer activities for new clinical products moving into CDMO sites.
  • Monitors contract manufacturer performance through routine reviews, meetings, and quality metrics.
  • Utilizes GMP-regulated quality management systems, including document control, change control, deviations/complaints, and corrective and preventative actions (CAPAs).
  • Facilitates the creation, review, and approval of relevant SOPs and work instructions relevant to CMC activities.
  • Provides QA support during CDMO audits, including participating in audit execution.
  • Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.

Qualifications and Skills
Required
  • Bachelor's degree in a scientific discipline (Chemistry, Biology, Engineering, or related field)
  • A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting manufacturing of sterile products.
  • Demonstrated experience providing sponsor-side quality oversight of CDMOs for sterile drug products, including batch record review, batch disposition, deviation management, and quality governance.
  • Working knowledge of aseptic processing, media fills, environmental monitoring, and sterility as applied in a CDMO model.
  • Strong understanding of cGMP regulations including FDA CFR Parts 210/211, EU Annex 1, ICH Q7, Q8, Q9, and Q10.
  • Detail oriented with strong organizational skills and the ability to manage multiple clinical programs and CDMO relationships simultaneously.
  • Self-directed and comfortable with a high degree of autonomy in a small-time, high-accountability environment.

Preferred
  • Experience with technology transfer of sterile Drug Products into new CDMO sites.
  • Experience with lyophilized products, pre-filled syringes, or other complex sterile dosage forms; experience in peptides is a plus.
  • ASQ Certified Quality Auditor (CQA) or similar.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients' lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

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