Pharmacy Technician Medical Device
Resume:
DEVIKA CHAND
Tracy, CA ***** 510-***-**** adhlfz@r.postjobfree.com
PROFESSIONAL SUMMARY
Experienced Manufacturing Reviewer / Quality Assurance Inspector with 14+ years of experience in the medical device and pharmaceutical industry. Adhere to Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOP). Strong cross-functional and team communication skills and ability to complete work effectively.
Computer Skills: Microsoft Office (Word, Excel) Outlook, SAP, Trackwise, Minerva, Viva Vault
PROFESSIONAL EXPERIENCE
INTARCIA THERAPEUTICS, INC., Hayward, CA 2019 – May 2020
Manufacturing Reviewer Associate
Reviewed documents in MFG (batch records, logbooks).
Provided feedback and coaching to technicians about any errors any corrections needed.
Developed training targeted to technicians on conducting a thorough review.
Discovered process discrepancies and resolved them, avoiding downtime.
Qualified additional technicians on review of Parts Preparation Record (PPR) and Batch Production Records (BPR).
As part of a team, provided feedback to managers and technicians to improve BPR process.
Ensured that all documents accurately reviewed and errors were corrected as part of the QA process.
Archived logbooks.
Provided timely feedback to process upon error identification for prompt correction.
IMPAX LABORATORIES INC. (AMENEAL PHARMACEAUTICAL INC.) Hayward, CA 2006 – 2018
Quality Assurance Inspector
Performed in-process testing, blend uniformity, particle size distribution, and AQL attribute inspection. Always ensured that procedures were followed accurately.
Performed real-time batch record review and verified data entries on quality records.
Performed Commercial MFG line clearance of processing rooms, equipment, instruments, and production.
Issued SOP-related documents to MFG.
Issued and archived logbooks.
Reviewed and approved executed production batch records, specifications, and SOPs.
Represented company during FDA audit/inspections.
Trained and qualified team members performed cleaning validation (CV).
AXYGEN, Union City, CA 2004 – 2006
Quality Inspector
Performed in-process audits and data entries.
Collaborated with Manufacturing to solve production issues and problems.
Batch record review.
Medical device inspections.
Performed cleaning validation.
EDUCATION
CAREER SOLUTIONS COLLEGE, Union City, CA
Pharmacy Technician
ADDITIONAL SKILLS
Certified Pharmacy Technician
Awarded as top performer for achieving highest quality standards for GDP.
Internship at St. Rose Hospital for two years as a Pharmacy Technician. Performed data entry and sterilized instruments.
Contact this candidate