Senior QA Auditor/Inspection Prep (GLP/GCLP/Large Molecule) – Direct Hire/Will Relo – RTP, NC Area
Our client, a niche CRO that provides lab and research services to biotech and pharmaceutical companies, is actively recruiting for a bright, knowledgeable and self-directed candidate to join its top-notch Quality team.
This is one of the fastest growing companies in the Triangle. It specializes in large molecule bioanalysis and provides support services from early discovery through pre-clinical studies and clinical phases. It maintains the highest quality standards and seeks the best and the brightest for its Quality team.
Company will pay excellent wage, including relo support, to attract and retain an excellent candidate.
Key Things to Note:
- This Quality Auditor will play a critical role in ensuring readiness for client and regulatory audits and inspections. Client prides itself on its clean audit track record, and seeks candidate with the knowledge and compliance orientation needed to ensure continued success.
- Role will involve QA reviews for compliance with SOPs, methods, GLP/GCLP regulations, etc. Seek candidate with thorough knowledge of GLP/GCLP reg’s and high aptitude for learning company SOPS, methods, etc.
- The company provides support services for biomarkers, immunogenicity, pharmacokinetics (PK), flow cytometry, and cell-based assays. Experience and education in large molecule bioanalysis will be important.
- This is an emerging company with a collaborative work dynamic and a strong client service orientation. Seek team player who is a quick study and brings an unwavering commitment to excellence.
- Perform Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
- Issue QA statements for reports as needed
- Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
- Assist in writing and reviewing QA standard operating procedures
- Reviews and assists in closing deviations, investigations, corrective actions, and preventive actions plans
- Positively impact the company through successful contributions, active participation and identification of compliance gaps
- Obtain and maintain professional and technical knowledge
- Participate in document management activities
- Training and leading of junior level QA staff as needed
Targeted candidate will offer a BS in related science and 3-7+ years working in a laboratory/bench role including substantial experience in a Quality role (GLP/GCLP). Experience working within a pharma, biotech and/or CRO setting will be important.
Other priorities include:
- Large molecule expertise
- Experience analyzing laboratory data and processes, to include data from assays and sample analysis
- Keen eye for detail
- Internal and/or external GxP auditing and inspection readiness experience
- Thorough knowledge of GLP/GCLP regulations and practices
- Excellent juggling skills, including ability to meet tight deadlines
- Strong oral and written communication skills, including compliant and clean documentation skills
- Proficiency in MS Excel and Word
This is an immediate need. Growth potential is enormous.
Please forward Word resume for prompt consideration.