More jobs:
Specialist QA; Regulated Industry
Job in
Coffeyville, Montgomery County, Kansas, 67337, USA
Listed on 2026-10-16
Listing for:
ProQuality Network
Full Time
position Listed on 2026-10-16
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Title: Specialist QA (Regulated Industry) – 3541050
Duration: Approximately 1 Year
Positions Available: 1
SUMMARYPro Quality Network is seeking a Specialist QA (Regulated Industry) for a one-year contract assignment supporting our client’s Quality Assurance program
. This role requires working under minimal supervision to provide quality oversight across manufacturing, validation, change control, and site quality systems within a regulated environment.
The selected candidate will ensure compliance with cGMP requirements, regulatory expectations, and internal quality standards while collaborating cross-functionally to support manufacturing operations, NPI initiatives, validation activities, and facility programs.
KEY RESPONSIBILITIES- Review and approve Product Master Plans (MPs).
- Review and approve process validation protocols and reports, including PPQ activities.
- Serve as Quality representative on incident triage teams.
- Review and approve Environmental Characterization reports.
- Authorize release of sanitary utility systems.
- Review and approve planned incidents.
- Lead deviation investigations and support root cause analysis and CAPA development.
- Lead and participate in site audits.
- Own and maintain site quality program procedures.
- Act as QA Manager designee on the local Change Control Review Board (CCRB).
- Review and approve risk assessments.
- Support Automation, Commissioning & Qualification (C&Q), PPQ, and FAT activities.
- Support facilities and environmental monitoring programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Review and approve Nonconformance (NC) investigations and CAPA records.
- Review and approve change control records.
- Perform lot disposition and authorize product release for shipment.
- Master’s degree with 2 years of directly related experience OR
- Bachelor’s degree with 4 years of directly related experience OR
- Associate degree with 8 years of directly related experience OR
- High School Diploma/GED with 10 years of directly related experience
- Degree in Science or Engineering
- Experience with NPI, Change Control, Documentation Review, Validation, C&Q, PPQ, and FAT
- Experience in regulated pharmaceutical or biotechnology environments
- Strong project management and organizational skills, with the ability to drive assignments to completion.
- Ability to initiate and lead cross-functional teams.
- Strong leadership, influencing, and negotiation skills.
- Solid knowledge of manufacturing, distribution, QA/QAL, validation, and process development.
- Experience interacting with regulatory agencies.
- Ability to assess compliance risks and implement corrective actions.
- Advanced data trending and analytical skills.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and database systems.
- Strong written and verbal communication, facilitation, and presentation skills.
- Ability to work independently while collaborating effectively across all organizational levels.
- Demonstrated alignment with professional leadership practices and company values.
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