Title: Specialist QA (Regulated Industry) – 3541050

Location: Hybrid/Remote (1.0 – 2.0 FTE, Overtime – Project Consultant) – Open to Puerto Rico Residents

Duration: Approximately 8 Months

Positions Available: 1

SUMMARY

ProQuality Network is seeking a Specialist QA (Regulated Industry) for an 8-month project consultant assignment supporting our client’s Quality Assurance program. This role requires working under minimal supervision to provide quality oversight in a regulated manufacturing environment.

The selected candidate will support aseptic processes, New Product Introduction (NPI), validation activities, change control, FATs, and PPQs while ensuring compliance with cGMP standards and regulatory expectations.

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.
• Represent QA on New Product Introduction (NPI) teams.
• Lead deviation investigations, including 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 activities, including FATs and validation execution.
• 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.

EDUCATION & EXPERIENCE REQUIREMENTS

• Doctorate degree OR
• 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 Qualifications:

• Experience in aseptic manufacturing environments
• Experience with NPI, Change Control, FATs, Validation, and PPQ
• Experience in regulated pharmaceutical or biotechnology industries

REQUIRED COMPETENCIES & SKILLS

• Strong project management skills with the ability to meet deadlines.
• Excellent organizational skills and ability to follow assignments through to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• In-depth knowledge of manufacturing, QA/QAL, validation, and process development.
• Experience interacting with regulatory agencies.
• Advanced data trending, analysis, and compliance evaluation 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 effectively collaborating across multiple organizational levels.
• Demonstrated alignment with professional leadership practices and company values.

If you meet the qualifications and are interested in this opportunity, we encourage you to apply through the job description link and submit your updated resume for consideration.