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QA Associate - Batch Record Reviewer

Actalent
locationSt. Louis, MO, USA
PublishedPublished: 6/14/2022
Technology
Full Time

Job Description

Job DescriptionJob Title: QA Associate
Job Description

The QA Associate is responsible for the rigorous review, verification, and archival of batch records and associated documentation to ensure compliance with internal SOPs, cGMP, and FDA regulations. This role is primarily desk-based and involves close collaboration with production, warehouse, and quality teams to resolve discrepancies and maintain data integrity.

Responsibilities

  • Perform comprehensive batch record reviews for completeness, accuracy, and compliance with GDP and SOPs.
  • Review supporting documentation including logbooks, protocols, packaging records, and inventory records.
  • Collaborate with production and management to resolve discrepancies or missing information in batch records.
  • Scan and archive completed records into the electronic database and physical storage system.
  • Input data into warehouse management systems (e.g., Dynamics 365) and quality systems (e.g., Reliance).
  • Ensure inventory values and documentation are accurately recorded and support initiatives within the QA team to build flexibility and coverage.
  • Participate in continuous improvement efforts and assist in training production staff on documentation best practices.
  • Cross-trained with other QA Associate functions including Document Control and Inventory Control.
  • Issue and control batch records, cleaning records, test sheets, and logbooks.
  • Maintain and control the company lot number system and ensure proper documentation flow.

Essential Skills

  • Strong interpersonal skills; able to work respectfully with cross-functional teams.
  • Self-motivated and organized with a high level of accountability.
  • Willingness to learn and adapt to evolving processes and systems.
  • Proficient in Microsoft Office and comfortable using ERP and quality systems (e.g., Dynamics 365, Reliance).
  • Excellent written and verbal communication skills.
  • Ability to work independently and collaboratively with minimal supervision.

Additional Skills & Qualifications

  • High School Diploma or GED required; Associate’s or Bachelor’s degree in a scientific or technical field preferred.
  • 1+ year of experience in pharmaceutical QA or FDA-regulated environment preferred.
  • Strong attention to detail and ability to work in a fast-paced, documentation-heavy environment.

Work Environment

This position is a Monday to Friday Day Shift role with a flexible start time between 7:00 - 8:30 AM, working 8-9 hours from there. The role includes 90% desk-based work in a shared office setting, with occasional lifting of up to 50 lbs. The manufacturing building is dusty due to the powdered products produced and is not a sterile environment. The team comprises 3 Inspectors, 1 Supervisor, 3 Batch Record Reviewers, 1 Document Control, and 1 Inventory Control.

Pay and Benefits

The pay range for this position is $22.00 - $26.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in St. Louis,MO.

Application Deadline

This position is anticipated to close on Jul 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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