Senior Compliance Auditor – Quality Assurance

Pharmalytica Services is a GLP and GMP compliant CRO providing analytical and bioanalytical testing and consulting services to the pharmaceutical industry. Our rapid growth and expansion are providing additional employment opportunities at our Newington, CT facilities for experienced professionals. Pharmalytica offers a challenging and stimulating work environment to increase your knowledge and expand your career horizons. Other benefits include company subsidized health insurance, paid vacation, tuition assistance and health club reimbursement.
REQUIREMENTS
Senior Compliance Auditor – Quality AssuranceExecute GMP and GLP Quality Assurance functions for analytical and bioanalytical testing of pharmaceutical and biotechnology products.
Perform In-phase study audits, Quality Systems audits and Vendor Audits.
Review and approve Analytical Reports, COAs, SOPs, Protocols, Methods, and Study Reports.
Track audit observations and perform trending analysis.
Support the CAPA program and initiate programs to improve compliance and quality.
Provide GLP/GMP training to analysts.
Assist the VP in hosting FDA and client auditors, preparation of the annual QA report to management and personnel performance evaluations.
Reports to the VP of Quality Assurance.
Previous experience in a pharmaceutical GMP/GLP analytical laboratory setting preferred.BS degree in a scientific discipline and 1 to 3 years experience in pharmaceutical quality assurance required.