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Salary: USD 91,500 - 137,300 / annual
Precision Medicine Group seeks a Quality Assurance Specialist III to provide advanced-level, hands-on support in a regulated GxP laboratory services and kitting production environment. This is a senior individual contributor role with significant responsibility for quality systems management, compliance oversight, and operational support.
Key responsibilities include:
Quality Function:
- Maintain and actively manage company-wide GxP quality systems, including logging, tracking, and documentation of non-conformances, customer complaints, planned deviations, change management, CAPA, supplier quality management, audit programs, employee training, and document & record control
- Participate on the Material Review Board and Safety Committee
- Schedule, perform, and report internal audits and supplier audits; serve as lead auditor
- Analyze monthly quality metrics and data to assess compliance health; present findings and propose solutions to management
- Respond to supplier look-back notifications and determine material disposition
- Monitor equipment calibration programs
- Independently conduct internal audits, supplier evaluations, and desk audits to identify performance issues and risk mitigation strategies
- Manage documentation and records during audits and inspections
- Lead departmental projects focused on operational process understanding and process mapping
- Act as change-agent and QA lead during continuous improvement and global harmonization efforts
- Provide guidance to junior QA specialists
- Engage in client-facing activities including leading client visits/audits, representing QA at project kick-offs and during customer complaint resolution
- Create and conduct site-wide training for multiple disciplines
Operations Support:
- Serve as quality lead for validation activities; review and approve validation protocols, reports, and documentation
- Review and accept customer specifications to conform to contractual requirements
- Generate and maintain label formats and Certificates of Analysis for manufactured and resale products
- Inspect and approve all product labels
- Develop and distribute controlled quality system documentation
- Develop and maintain databases and spreadsheets for document control
- Maintain filing and storage systems for document control, training, and batch records
- Perform area walkthroughs and audits for compliance
- Collaborate with Project Management on quality deliverables and compliance accountability
Inspection and Release:
- Inspect and release incoming raw materials, critical components, packaging, and labeling per specifications and SOPs
- Perform batch record review and release for finished products, raw materials, intermediate solutions, and services
- Conduct product inspections and review repack records
Additional responsibilities include assisting in training, participating in regulatory and customer audits, providing backup coverage, and carrying out other assigned duties. Extended work hours may be necessary to meet business demands.
Qualifications:
Minimum Required:
- Bachelor's Degree or equivalent combination of education and experience
- 4 years of related experience in a life science, regulated environment
Other Required:
- Experience working in a Quality Department/Life Sciences-Regulated environment, including independent internal audits, technical and quality document review, batch release, and incoming inspection
- Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
- Must become an active member of Society for Quality Assurance (SQA); company will support membership fees
- Ability to meet deadlines and perform administrative functions
- Microsoft Office suite proficiency (Word, Excel, PowerPoint)
- Ability to organize tasks, work independently, and adapt to changing priorities
- Ability to function independently within a minimally supervised environment with exceptional attention to detail
- Highly developed communication skills including writing, verbal, and interpersonal skills
- Fluent English language proficiency (read, write, speak, comprehend)
Preferred:
- Clinical quality experience
