We are seeking a Specialist QA with strong expertise in quality systems, validation, manufacturing processes, and regulatory compliance. The selected candidate will perform various QA functions to ensure product and process integrity, compliance with cGMPs, and successful support of manufacturing, engineering, automation, and supply chain operations. This role requires minimal supervision and involves direct engagement with cross-functional teams and regulatory-facing activities.
Key Responsibilities
- Review and approve:
- Manufacturing procedures (MPs)
- Process validation protocols and reports
- Environmental characterization reports
- EMS/BMS alarms
- Work Orders
- Planned incidents
- Non-conformance investigations and CAPA records
- Change controls
- Provide QA support to:
- Incident triage teams
- Facilities, environmental programs, and automation initiatives
- New Product Introduction (NPI) teams
- Lot disposition and shipment authorization
- Lead and represent QA in:
- Site audits and regulatory inspections
- Investigations and site quality program procedures
- CCRB meetings (as QA Manager designee)
- Cross-functional and quality-related initiatives
- Evaluate and review risk assessments and compliance-related issues
- Support quality oversight of supply chain and incoming materials operations
- Maintain strong documentation practices and ensure compliance with GxP standards
Key Competencies
- Strong project management and organizational skills
- Independent and collaborative work style
- Excellent written and oral communication, facilitation, and presentation skills
- Advanced data trending and compliance evaluation
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.)
Requirements
Qualifications
- Educational background in Life Sciences or Engineering
- One of the following:
- Doctorate degree
- Master’s degree with 2+ years of directly related experience
- Bachelor’s degree with 4+ years of directly related experience
- Associate degree with 8+ years of directly related experience
- High school diploma/GED with 10+ years of directly related experience
Preferred Qualifications
- Expertise in Quality Systems (e.g., deviations, CAPA, change control)
- Experience with:
- GxP application validation, VMPs, IQ/OQ/PQ protocols
- Commissioning and qualification for new drug substances/products
- Electronic systems: CDOCS, Maximo, Trackwise, LIMS, MES, SAP
- Demonstrated ability to:
- Interact with regulatory agencies
- Lead investigations and audits
- Influence and negotiate across functional teams
- Evaluate and resolve compliance issues
- Experience providing QA oversight in support of automation and engineering
- Fully bilingual (English/Spanish)
Benefits
- 1–3-year contract with possible extension
- 3rd Shift
- Administrative Shift
