QA Manager - On Site in Austin, Texas at PHARMALOGIC HOLDINGS

Assure equipment is functional, within calibration, suitable for use, maintained and documented per SOP. Assure equipment qualified and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents.

Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies reported to PharmaLogic Quality and Regulatory.

Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management.

Site lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records, personnel, and facility review.

Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review. Draft ANDA related documents for submission including annual reports and other updates as required.

Conduct periodic and annual quality audits, training, SOP review and other activities as directed

Job Requirements │ Skills │Education:

BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3-5 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience preferred. Pharmacy tech certification a plus; experience with aseptic technique a plus

Experience working with ionizing radiation and laboratory equipment desirable including troubleshooting and repairs.

Strong analytical, critical thinking and customer service skills. Experience working on a cross-functional team in fast-paced environment.

Strong knowledge of cGMP environment and regulations. Knowledge of CFR21 Part 212 preferred.

Strong attention to detail and experience with managing multiple projects and priorities.

PharmaLogic offers a competitive compensation package and superior benefits.

Come join our winning team and begin a fulfilling career with us by applying today.

PharmaLogic is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.