Quality Assurance Control
Resume:
Jacqueline (Jackie) Schonewolf x
Pennsauken, NJ 08109
Phone 609-***-****
jacquelineschonewolf @netzero.net
SUMMARY
Dedicated, experienced and detailed oriented with proven ability to multi-task. Work well
independently and in team environment. Ability to prioritize tasks and adapt to changing
environment. Capabilities and expertise include: 35 years of Quality Assurance experience in
vaccine, biologics & packaging within the pharmaceutical Industry.
Quality Control
Them
November 2021-Present
e Worked in a cGMP environment and responsible for adhering to all applicable
SOPs and safety guidelines.
e Reviewed production batch records for accuracy and completeness.
CATALENT - Cl
ical QA Inspector Production Feb 2013-November 2021
e Responsible for ensuring that Standard Operating Procedures are consistently
followed, and that cGMP's are observed, while packaging operations. This may
require the simultaneous auditing and/or monitoring of one or more operations.
¢ Verifies and reconciles materials to and from Clinical Production rooms and works
accordingly with Production, Materials Management and Project Management to
handle any possible discrepancies.
e Inspects and releases all clinical packaging rooms to ensure that they have been
properly cleaned and that all materials have been removed. Documents all activities
accordingly 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 (if
necessary) for any jobs using validated or non-validated equipment respectively.
e Reviews and understands both the Production Protocol and QA Protocol prior to
starting the Clinical Packaging process.
SENIOR LEVEL QUALITY CONTROL / MANUFACTURING PROFESSIONAL
Highly motivated Individual with over 20 years experience in Fortune 200 Companies.
Dependable top performer highly regarded as a self-motivated and trustworthy quality assurance
professional. Strengths include attention to detail, ability to motivate and ability to grasp new
processes expediently. Areas of expertise include:
PERMA PURE, TOMS RIVER, NJ SUPERVISOR OF QUALITY
Oversee the daily activities of the QC department including but not limited to time sheets
and vacation request. Documentation is filled out correctly.
Train new employees
Run optical comparator and Uson tester.
Do physical inspection of chemical, incoming components and finished goods
New member of the internal audit team
Follow GMP standards
Work in FDA environment
Interactions with upper management especially if deviations occurred
Integra Life Sciences Corporation, Plainsboro, NJ 08536
Product Release Specialist
2006 -2011
* Reviewed Device History Records (DHR) to verify calculations, product accountability,
accuracy, and proper GMP documentation practices and prepare them for final review
and product release
«Assigned expiration dates for Integra Skin Products
Track Ethylene Oxide, Radiation, and Gamma sterilization paperwork
* Initiated Certificates of Compliance for Integra LifeSciences OEM partners and
customers
« Reviewed and approved in-house computer-generated product labels
«Trained new employees to review DHRs
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