QA Specialist (Regulated Industry) 3540988

ProQuality Network; Coffeyville (KS); Hybrid; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA (Regulated Industry) for a contract assignment to support our client’s Quality Assurance program, ensuring compliance with cGMP and internal quality systems with minimal supervision.

The role oversees manufacturing, validation, change management, investigations, audits, and site quality programs; reviews MPs, validation reports, CAPAs, and risk assessments, and acts as QA Manager designee on CCRB, ensuring release decisions are compliant.

Qualifications

• Master’s degree with 2 years related experience or higher.
• Bachelor’s degree with 4 years related experience.
• Associate degree with 8 years related experience.
• High School Diploma/GED with 10 years related experience.

Responsibilities

• Review and approve MPs and validation reports (including PPQ).
• Lead deviation investigations and root cause analyses.
• Own site quality program procedures and CCRB risk reviews.
• Perform lot disposition and authorize product release for shipment.
• Lead site audits and ensure QA/QAL processes are compliant.

Skills

Project management

Cross-functional leadership

Regulatory compliance

QA/QAL processes

Data analysis

Documentation review

Communication

Education

Master’s degree

Bachelor’s degree

Associate degree

High School Diploma/GED

Job description

QA Specialist (Regulated Industry) 3540988

Title: Specialist QA (Regulated Industry) – 3540988

Duration: Approximately 5 Months

Positions Available: 1

SUMMARY

ProQuality Network is seeking a Specialist QA (Regulated Industry) for a contract assignment supporting our client’s Quality Assurance program. This role is responsible for ensuring compliance with regulatory standards and internal quality systems under minimal supervision.

The selected candidate will provide quality oversight across manufacturing, validation, change management, investigations, and site quality programs, ensuring adherence to cGMP requirements and regulatory expectations.

KEY RESPONSIBILITIES

• Review and approve product Master Plans (MPs).
• Review and approve process validation protocols and reports (including PPQ).
• 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 and support deviation investigations and root cause analyses.
• 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, facilities, and environmental programs.
• Review and approve Work Orders and 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.

EDUCATION & EXPERIENCE REQUIREMENTS

• 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

Preferred Background:

• Bachelor’s degree in Science or Engineering
• Experience in Change Control, Documentation Review, Validation, and PPQ
• Experience in regulated pharmaceutical or biotechnology environments

REQUIRED COMPETENCIES & SKILLS

• Strong project management and organizational skills, with the ability to drive assignments to completion.
• Proven ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• In-depth knowledge of manufacturing, validation, QA/QAL processes, and process development.
• Experience interacting with regulatory agencies.
• Ability to evaluate compliance risks and implement corrective actions.
• Advanced data trending and analytical skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and database systems.
• Excellent written and verbal communication skills, including facilitation and presentation abilities.
• Ability to work independently and collaborate effectively across multiple organizational levels.