The QA Specialist assists and supports the organization with compliance and ongoing conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Ensures control of internal quality policies and procedures. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.
- Perform review of analytical data and support laboratory operations
- Maintain internal controls over quality policies, procedures, and specifications, ensuring effective versions of procedures are available to employees for implementation
- Facilitate changes to SOPs, policies, training materials, and other documents
- Track and trend quality systems (Investigation, CAPA, training, etc.)
- Notify management of quality/compliance trends or failures
- Ensure systems used in QA are properly maintained (e.g., QA audit records, training records)
- Perform technical review of manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. This may include approval of batch records, summary reports and other release documentation
- Perform protocol, data, and report review to verify conformance to applicable SOP and regulatory requirements
- Support GXP compliance and inspection readiness within organization
- Perform internal and external audits for GXP compliance
- Evaluate responses to inspection reports and perform follow-up with respondents, management, or others, as applicable, to ensure resolution
- Assist during regulatory inspections.
Pearl is an equal opportunity employer. We celebrate and seek to build upon the diversity of backgrounds reflected by our highly motivated, talented, and productive team.
- A BS in Life Sciences, or equivalent
- Minimum of five years of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP studies; experience with product development is a plus. At least two years of experience in Quality Assurance preferred.
- Demonstrated knowledge of Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer.
- First-hand experience in planning, writing and reviewing Standard Operating Procedures
- Exceptional interpersonal, problem-solving, and written/verbal communication skills.
Pearl offers its full time employees a competitive set of medical and other benefits.
Qualified applicants please submit your resume to Pearlofajob@PearlTherapeutics.com and include the job reference number listed on the job description.
Principals only, please.
Pearl Therapeutics Inc. - 10 months ago