| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Street Address Westwood LanePennsauken, NJ Street Address
Phone PHONE NUMBER AVAILABLEjacquelineschonewolf @netzero.netSUMMARYDedicated, experienced and detailed oriented with proven ability to multi-task. Work wellindependently and in team environment. Ability to prioritize tasks and adapt to changingenvironment. Capabilities and expertise include: 35 years of Quality Assurance experience invaccine, biologics & packaging within the pharmaceutical Industry.Quality ControlThemNovember 2021-Presente Worked in a cGMP environment and responsible for adhering to all applicableSOPs and safety guidelines.e Reviewed production batch records for accuracy and completeness.CATALENT - Clical QA Inspector Production Feb 2013-November 2021e Responsible for ensuring that Standard Operating Procedures are consistentlyfollowed, and that cGMP's are observed, while packaging operations. This mayrequire the simultaneous auditing and/or monitoring of one or more operations. Verifies and reconciles materials to and from Clinical Production rooms and worksaccordingly with Production, Materials Management and Project Management tohandle any possible discrepancies.e Inspects and releases all clinical packaging rooms to ensure that they have beenproperly cleaned and that all materials have been removed. Documents all activitiesaccordingly in the associated logbook.e Supports and assists Mechanics on the execution of Operational Verifications (OVs)and Set-Up Records (SURs) both prior to the start and during the process (ifnecessary) for any jobs using validated or non-validated equipment respectively.e Reviews and understands both the Production Protocol and QA Protocol prior tostarting the Clinical Packaging process.SENIOR LEVEL QUALITY CONTROL / MANUFACTURING PROFESSIONALHighly motivated Individual with over 20 years experience in Fortune 200 Companies.Dependable top performer highly regarded as a self-motivated and trustworthy quality assuranceprofessional. Strengths include attention to detail, ability to motivate and ability to grasp newprocesses expediently. Areas of expertise include:PERMA PURE, TOMS RIVER, NJ SUPERVISOR OF QUALITYOversee the daily activities of the QC department including but not limited to time sheetsand vacation request. Documentation is filled out correctly.Train new employeesRun optical comparator and Uson tester.Do physical inspection of chemical, incoming components and finished goodsNew member of the internal audit teamFollow GMP standardsWork in FDA environmentInteractions with upper management especially if deviations occurredIntegra Life Sciences Corporation, Plainsboro, NJ 08536Product Release Specialist2006 -2011* Reviewed Device History Records (DHR) to verify calculations, product accountability,accuracy, and proper GMP documentation practices and prepare them for final reviewand product releaseAssigned expiration dates for Integra Skin ProductsTrack Ethylene Oxide, Radiation, and Gamma sterilization paperwork* Initiated Certificates of Compliance for Integra LifeSciences OEM partners andcustomers Reviewed and approved in-house computer-generated product labelsTrained new employees to review DHRs[II O < |
