Specialist QA

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 83,000 - 124,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Quality Assurance professional to oversee a broad QA remit across manufacturing, facilities, utilities, environmental programs, and quality systems.

You will review critical GMP documentation, lead investigations, support audits, and provide lot disposition for product release while ensuring regulatory compliance and robust QA processes.

Qualifications

• Advanced knowledge of cGMP documentation review and approval.
• Experience leading investigations and ensuring compliant closures.
• Proven ability to support audits and inspections.
• Experience with validation and computer systems validation preferred.

Responsibilities

• Review and approve MPs, change controls, and CAPA records.
• Lead investigations and ensure timely, compliant closure.
• Coordinate with QA on audits, inspections, and regulatory interactions.
• Provide lot disposition and support product release decisions.

Skills

QA processes

GMP compliance

Investigations

Audits

CAPA

Change controls

Data trending

Regulatory liaison

Education

PhD or MSc in a relevant field

Bachelor's + 4+ years experience

Advanced degree with clinical manufacturing exposure

Tools

MES/EBR

SAP

TrackWise

EDMQ

Job description

Under minimal supervision, this role performs a wide range of Quality Assurance activities to ensure compliance across manufacturing, facilities, utilities, environmental programs, and quality systems. Responsibilities include review and approval of critical GMP documentation, leading investigations, supporting audits, and providing lot disposition for product release.

Responsibilities

• Review and approve product master records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Approve Environmental Characterization reports.
• Approve planned incidents and support incident triage activities.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve nonconformance investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.
• Own and maintain site quality program procedures.
• Review and assess risk assessments.
• Lead investigations and ensure timely, compliant closure.
• Lead site audits and support internal/external inspections.
• Evaluate compliance issues using advanced data trending and analysis.
• Serve as designee for QA management on local change control review boards (CCRB).
• Support automation, facilities, and environmental programs.
• Represent QA on New Product Introduction (NPI) teams.
• Collaborate with Manufacturing, Process Development, Validation, Quality Control, Engineering, Facilities, Utilities, and Contractors.
• Coordinate with external resources when higher-level expertise is required.
• Interact effectively with regulatory agencies.

• Doctorate OR

• Master's + 2 years of directly related experience OR
• Bachelor's + 4 years of directly related experience OR
• Associate's + 8 years of directly related experience OR
• High School/GED + 10 years of directly related experience

Preferred Qualifications:

• Experience performing on-the-floor Plant Quality Assurance (PQA) activities, including review, approval, and tracking of cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise.
• Expertise in deviations, CAPAs, change controls, and validation activities.
• Experience with procedural compliance and initiate deviation records during on-the-floor triage.
• Experience supporting audits and inspections as part of the audit/inspection management team.
• Experience with computer systems validation or computer systems quality assurance (medical device or consulting background preferred).
• Experience with validation of GxP applications (VMP, IQ, RA/GxP assessment, OQ, PQ, test scripts, summary reports).
• Experience serving as Quality Contact for complex new-product projects.
• Experience in commissioning and qualification.
• Project management and organizational skills.

Shift & Contract Details

• Non-Standard Shift
• 6-month contract with possible extension