Adrianna Gray
Norristown,PA
Summary
Dynamic Quality Assurance professional with extensive experience at Merck, excelling in cGMP compliance and CAPA management. Proven track record in leading deviation investigations and developing SOPs, driving continuous improvement initiatives. Adept at fostering cross-functional collaboration and enhancing audit readiness, ensuring high-quality standards in pharmaceutical operations.
Overview
22
22
years of professional experience
Work History
Quality on the Floor Packaging Manager
Emergent BioSolutions
Baltimore, MD
08.2018 - 07.2020
- Provided on-the-floor QA oversight through real-time batch record review, in-process auditing, GMP walkthroughs, and inspection readiness activities, including documentation and escalation of observations.
- Reviewed and approved GMP documentation (batch records, MBRs, SOPs, logbooks, work orders, engineering runs) and recommended product disposition based on QA assessment.
- Led deviation management activities, including risk assessments, root cause investigations, CAPA tracking, and implementation of solutions to support compliant manufacturing operations.
- Trained and mentored manufacturing and packaging personnel, represented QA in cross-functional meetings, and tracked/trended QA metrics to drive continuous improvement.
- Baltimore, MD
Sr. Quality Assurance Specialist
Johnson & Johnson McNeil
Fort Washington, PA
01.2018 - 08.2018
- Reviewed and approved Master Batch Records and executed batch records for accuracy, completeness, and cGMP compliance; released acceptable batches.
- Provided on-the-floor QA support during manufacturing and packaging operations, including line clearance, label checks, and cleaning verification.
- Ensured manufacturing, packaging, and warehouse activities complied with cGMPs, SOPs, and regulatory requirements.
- Reviewed, approved, and maintained SOPs and quality documentation, including validation/qualification reports, change controls, and batch-related records.
- Tracked, trended, and supported investigations for deviations, quality events, complaints, recalls, and field alerts.
- Inspected and released raw materials, clinical/commercial products, and manufacturing supplies; supported regulatory and client audits.
- Fort Washington, PA
Clinical Data Manager
Janessen Pharmaceutical
Horsham, PA
06.2015 - 12.2017
- Performed and managed manual data migration of open CAPAs and effectiveness checks from audit databases and repositories into the CAPA platform (pre- and post-go-live).
- Entered and maintained CAPA records in electronic systems, ensuring data accuracy, quality, and adherence to established conventions.
- Monitored new audit observations and supported ongoing CAPA entry and tracking until system interfaces were implemented.
- Generated weekly and monthly CAPA trackers, metrics, dashboards, and management presentations for senior leadership review.
- Managed audit-related documentation, including shared mailbox coordination, organization, filing, and archival of CAPA support records.
- Supported project implementation activities, including BI reporting development, user training, PSMF data management, and cross-functional status updates.
- Horsham, PA
Sr. Quality Specialist
Jazz Pharmaceutical
Philadelphia, PA
01.2015 - 06.2015
- Supported QA activities across pharmaceutical development, manufacturing, and post-marketing, including maintenance of quality systems and oversight of supplier/vendor qualification and audit programs (GCP, GLP, GVP; CMOs, CROs, labs, and clinical sites).
- Ensured effective documentation, tracking, and closure of CAPAs, deviations, and change controls within local and global quality systems.
- Led and contributed to the development and implementation of QA SOPs, tools, and systems, and supported regulatory and internal inspections through audit readiness and inspection participation.
- Philadelphia, PA
Sr. Quality Assurance Specialist
Merck
West Point, PA
08.2010 - 04.2014
- Provided on-the-floor Quality support to sterile and non-sterile manufacturing operations (bulk, liquid, lyophilization, inspection), advising Production on cGMP compliance and quality decisions.
- Performed technical review, approval, and release of batch records, finished products, and cGMP documentation; collaborated cross-functionally to resolve deviations, discrepancies, and investigations.
- Led training for production staff, supervisors, and QA auditors on cGMP documentation, audit readiness, and inspection responses; authored and revised Quality and Operations SOPs.
- Managed quality metrics and compliance systems, including CAPAs, change controls, deviations, validation activities (IQ/OQ/PQ), and supported regulatory and internal inspections.
- West Point, PA
Sr. Quality Release Associate
Merck
West Point, PA
08.2005 - 08.2010
- Served as liaison between Product Release and Operations, resolving batch record issues for packaging, bulk manufacturing, liquid filling, lyophilization, and sterile supply operations.
- Performed comprehensive quality review and control of batch records, packaging and sterilization documentation, product disposition, and release status using TrackWise, IMPACT, WATS, and quarantine/rejection systems.
- Improved release cycle times and document accuracy by supporting Right First Time and Lean Six Sigma initiatives, training production and quality staff, and coordinating closely with production and planning teams.
- West Point, PA
Filler/Inspector/Packaging Operator
Merck
West Point, PA
08.1998 - 08.2005
- Operated and monitored sterile filling, stoppering, tray loading, inspection, and packaging equipment for liquid and dry powder vaccine products, ensuring correct components, labeling, and line setup.
- Performed 100% visual inspection, in-process SPC sampling, documentation, and defect tracking; ensured quality compliance before, during, and after filling and packaging operations.
- Maintained cGMP compliance through equipment cleaning, line clearance, material inspection, labeling control, housekeeping, and accurate batch and production recordkeeping.
- West Point, PA
Education
Bachelor of Science -
Gwynedd Mercy University
Gwynedd Valley, PA01-2015
Skills
- CGMP and GMP compliance
- Batch record review
- SOP development
- Deviation investigation
- CAPA management
- Change control processes
- Audit and inspection readiness
- Lean Six Sigma Green Belt
Timeline
Quality on the Floor Packaging Manager
Emergent BioSolutions
08.2018 - 07.2020
Sr. Quality Assurance Specialist
Johnson & Johnson McNeil
01.2018 - 08.2018
Clinical Data Manager
Janessen Pharmaceutical
06.2015 - 12.2017
Sr. Quality Specialist
Jazz Pharmaceutical
01.2015 - 06.2015
Sr. Quality Assurance Specialist
Merck
08.2010 - 04.2014
Sr. Quality Release Associate
Merck
08.2005 - 08.2010
Filler/Inspector/Packaging Operator
Merck
08.1998 - 08.2005
Bachelor of Science -
Gwynedd Mercy University