QA Documentation Assistant - Release

Technology Partners is currently seeking a talented QA Documentation Assistant - Release.

Do you have experience with cGMP document review and auditing within a manufacturing environment?

Let us help you make your next big career move a reality!

You will perform usage decisions on inspection of lots of packaging components and intermediates to ensure conformance to current good manufacturing practices (cGMPs), SOPs, and plant quality standards. You will be responsible for reviewing in-process records and quality assurance test results for compliance with specifications, assigning dispositions, and determining expiry dating for finished goods packaging. Additionally, you will audit all manufacturing and packaging documentation to ensure timely release to meet production requirements.

• Review production records, including batch manufacturing, packaging records, and MES production reports, for accuracy and completeness.
• Audit manufacturing and packaging documentation to ensure compliance with GMP regulations and internal quality standards.
• Release bulk intermediates and package component materials to support production schedules.
• Issue and reconcile manufacturing, packaging, and QC laboratory documentation according to SOPs.
• Maintain and update essential databases, including metal reject reports, QA product labels, and release charts.
• Coordinate priorities with other QA or SQA staff to ensure top-priority work is accomplished efficiently.
• Gather and compile QA information to support investigations with batch record reviews and mathematical audits.
• Write and update/revise SOPs within the area of focus.
• Perform audits in production areas and collaborate with supervisors to provide direction on inspection criteria and CAPAs.

• Education:High School degree or GED is required.
• Experience:At least 5 years of experience in a document review or auditing role within a cGMP industry.
• Technical
  
  Skills:
  
  Previous experience using SAP, MES, or other automated inventory systems.
• Software:Strong personal computer skills, specifically with Microsoft software.
• Abilities:Demonstrated leadership in auditing/reviewing cGMP documentation, accurate mathematical calculation skills, and legible handwriting.
• Communication:Excellent interpersonal, written, and oral communication skills with the ability to work effectively in a team environment.
• Physical:Physically able to lift up to 50 pounds.

• College background or additional secretarial/administrative certifications.
• Experience with global audit databases (e.g., AIDa) and CAPA entry/follow‑up.
• Experience in coordinating priorities across multiple departments like Supply Chain and Production.

$36.93 - $52.75 /hr.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide sponsorship at this time or accept candidates who would require a corp‑to‑corp agreement.

If this position sounds like you,
WE SHOULD TALK!

Your better future is ready, and we want to put the right tools in your hands to get you there. Let's go!

Keywords:QA, Quality Assurance, Documentation Assistant, Release, cGMP, SOP, Audit, SAP, MES, Batch Records, Manufacturing, Compliance

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All offers of employment at Technology Partners are contingent upon clear results of a thorough background check and drug screening that meet corresponding laws and regulations at the city, state and federal level.

Pay ranges are influenced by candidate qualifications, experience, and role specifics, with the actual rate determined considering skills, market conditions, and are subject to change by the employer; pay negotiations follow all state and federal legal guidelines.