QA Specialist (Biotechnology Industry) 3564068
Specialist QA (Biotechnology Industry)
Job ID: 35464068
Location: Puerto Rico (Open to local residents)
Shift: Non-Standard Shift
Position Type: Contract (Approx. 6 months)
Openings: 1
Employer: ProQuality Network (supporting our client)
Overview
We are seeking a Quality Assurance Specialist to support our client’s Quality Assurance program within the biotechnology industry. This role operates with minimal supervision and plays a critical part in ensuring compliance, product quality, and regulatory excellence across manufacturing operations.
Key Responsibilities
- Perform Quality disposition (approval or rejection) of bulk drug substances
- Provide QA oversight to ensure manufacturing, testing, storage, and distribution comply with:
- cGMP (Current Good Manufacturing Practices)
- cGLP (Current Good Laboratory Practices)
- Applicable regulatory requirements
- Identify, document, and ensure proper handling of deviations
- Evaluate and assess change controls that may impact product quality
- Review production records and test results for accuracy, completeness, and compliance
- Ensure alignment of:
- Facilities
- Equipment
- Materials
- Processes and procedures
- with regulatory expectations
- Lead and support continuous improvement initiatives
- Maintain compliance with training requirements
- Collaborate cross-functionally to ensure Quality Management System (QMS) processes are executed effectively
- Support internal and external audits/inspections, acting as QA representative when needed
- Escalate risks related to quality, compliance, safety, or supply to senior management
- Provide QA oversight for New Product Introduction (NPI) activities
Core Functions
- Review and approve Master Production Records (MPs)
- Approve process validation protocols and reports
- Participate in incident triage teams
- Review and approve:
- Environmental characterization reports
- Planned incidents
- Work orders
- EMS/BMS alarms
- Support sanitary utility system release
- Represent QA in NPI teams
- Lead:
- Investigations
- Site audits
- Own and manage site quality procedures
- Act as QA designee in Change Control Review Board (CCRB)
- Review risk assessments
- Support automation, facilities, and environmental programs
- Approve:
- Non-conformance investigations
- CAPA records
- Change controls
- Perform lot disposition and authorize product release
Preferred Qualifications
- Background in Life Sciences, Engineering, or related field
- Strong expertise in Quality Systems, including:
- Deviations / Non-conformances
- CAPA
- Change Control
- Experience with systems such as:
- CDOCS
- Maximo
- TrackWise
- LIMS
- MES / Electronic Batch Records
- SAP
- Experience in Computer Systems Validation (CSV) or Computer Systems QA
- Knowledge of GxP systems validation, including:
- Validation Master Plans
- Risk assessments
- IQ/OQ/PQ protocols
- Test scripts and validation reports
- Strong understanding of manufacturing, QA, QC, and process development operations
- Experience supporting complex projects (NPI, packaging, inspection, commissioning, qualification)
- Proven ability to interact with regulatory agencies
- Fully bilingual (English & Spanish)
Education Requirements
- Doctorate degree OR
- Master’s + 2 years of relevant experience OR
- Bachelor’s + 4 years of relevant experience OR
- Associate’s + 8 years of relevant experience OR
- High School Diploma/GED + 10 years of relevant experience
Key Competencies
- Strong project management and organizational skills
- Ability to lead and collaborate with cross-functional teams
- Excellent problem-solving, influencing, and negotiation skills
- Advanced knowledge of:
- QA systems
- Validation processes
- Manufacturing and distribution operations
- Strong data analysis and trending capabilities
- Excellent written and verbal communication skills
- Ability to work independently and across all organizational levels
- Proficiency in:
- Word processing
- Spreadsheets
- Presentations
- Ability to assess and manage compliance risks effectively
Ready to Apply?
If you are a driven Quality professional looking to make an impact in a dynamic biotechnology environment, we encourage you to apply.
👉 Submit your application through the job description link with your updated resume. We look forward to connecting with you!