267-***-****

Justin Tucker

• Seasoned candidate with 10+ years of experience with Quality

Assurance.

• Well-versed with all the regulatory and compliances in the related field.

• He directly reported to the QA Manager/ QA Engineer.

• He conducted Quality Assurance procedures according to FDA guidelines Standard Operating Procedures (SOPs) and (cGMP) current Good Manufacturing Practices regulations.

• Worked in regulatory, quality, operations, and

pharmaceuticals

Authorized to work in the US for any employer

Contractor (Insight Global) Merck Quality

Auditor March 2020– April 2020

I was responsible for auditing 12 BLA sections, consisting of approximately 200 pages in total. The content of the of the sections may include process development and validation for Drug Substance, Drug Product, Packaging, Analytical and/or Facilities. As the Auditor I would provide 100% verification of data and conclusions back to source documents. Comments will be raised for any clarification needed, and the Auditor will partner with the Technical Author of the section for prompt and effective comment resolution. Johnson & Johnson (Contract) Scientist Associate November 2019- Feb 2020 Sample management, requisitions, documentation management, inventory control and management, and analysis of specimens.

• Putting in sample type, matrix collection of the sample

• All data that is being used for the sample

• Take sample, assign requisition number, then we add it into BSI with all details (how many

specimens, matrix collection, whole blood or whole urine, stool sample, etc.)

• Transfer from Springhouse biobank to a scientist (international or local) and we’ll do a pool

task, box transfer task, etc. all tasks are within the requisition

• Then sent to depository where the scientist there can do everything they need with

Justin Craig Tucker

with

inventory, once done it’s sent back to us

Quality Assurance Coordinator

Johnson Matthey April 2019 to

July 2019

The function of this position is to coordinate QA lot release activities for product made in Production and Samples Groups. This person maintains the electronic database for lot status, maintains records for waivers and lot folders, and drives lot release to completion.

• Provides final product release prior to shipment.

• Maintain good communication with Production, Material Control, and Quality Control to compile timely and accurate records.

• experience with suppliers and vendors relevant to the standard of quality of products released to the client.

• Direct processing and maintenance of records.

• Assemble data packs for all lots prior to shipment and ensure product is within specifications. • Contact various departments concerning discrepancies in test results to prevent delayed shipments or release of non-conforming material.

• Revise testing requirements, procedures, and forms whenever specifications change.

• Prepare Certificates of Analysis for manual and electronic data transfer.

• Coordinate testing and auditing priorities with Quality Control to support shipments.

• Coordinate records inventory activities.

• Interface with supply chain to acquire applicable documentation.

• To set priorities for the off-shift records coordinator to ensure that the daily priorities are met.

• Track the scheduling and test status of all validation lots and provide the completed folders to the QA Manager or Quality Engineer for completion of PPAP/PSW or first lot paperwork submission.

• Comply with all environmental & health and safety federal, state, local regulations and company policies.

Quality Control Inspector Sharp

Corporation - Conshohocken, PA

November 2018 to January 2019

• Responsible to ensure and enforce GMP compliance including gown attire, personnel hygiene, handling and storage of materials and good documentation practices throughout the production floor.

• Ensure room/equipment cleaning logs have been completed as applicable.

• Ensure all assets are documented in the batch record, all equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the batch is listed on the equipment verification pages and all applicable challenges are in the batch record.

• All equipment is calibrated; verify incoming components attributes (lot#, expedite, description, item# and quantity) against work order, component receipt, return form and other supporting documentation within the batch record.

• Ensure batch record documentation is accurate, AQL report is accurate, all change controls have been made.

• Read and Understand process steps within the batch record to ensure compliance during the packaging procedure.

• Review batch record for any additional requests, memos, deviations, change controls etc.

• Responsible to perform all in process inspections, verify challenges and pull testing or retain samples as required.

• Perform inspections as required in batch record and as per AQL requirements.

• Inspections may include visual, functional, destructive and count checks.

• Verify challenges were performed according to SOP and batch record.

• Pull and identify customer samples as per batch records requirements.

• Responsible to ensure batch record is being executed by all associates according to the process steps.

• Responsible to verify major and minor cleans as well as proper completion of all corresponding logbooks.

• Periodic review of logbooks for completeness and accuracy.

Verification and Quality Assurance /Laboratory

Technician GSK GlaxoSmithKline - Collegeville, PA May 2018 to September 2018

• Archived samples in Excel spreadsheets in the laboratories for the science departments.

• Worked on the Discovery and Supply team to setup and help with the completion of the new UP12 Freezer Farm for storage of thousands of samples for GSK scientist.

• Worked with the scientist in the Biology and Chemistry groups to make sure the data archived was the correct information that was uploaded to the team site.

• Worked in the laboratory Freezers labeling and barcoding the samples that needed to be uploaded to the new software for the new state of the artUP12 Freezer Farm at GSK.

• Lead meetings and group discussions with project performance issues, project time deadlines, and giving PowerPoint presentations.

• Specimen collection with transportation and preservation of the samples throughout laboratories.

• Labeling and Barcoding for the archiving, storage and integrity of the samples in the UP12 Freezer Farm.

Employment Gap: Oct 2016 - Apr 2018

• Took some time off due to family emergency.

Scientist Associate

Catalent Pharma Solutions - Philadelphia,

PA July 2016 to September 2016

Verification and Quality Assurance

• Conducted Quality Assurance procedures according to FDA guidelines Standard Operating Procedures (SOPs) and (cGMP) current Good Manufacturing Practices regulations on Drug that was being utilized for clinical trials.

• Performed Verification checks on patient drug and documentation for the clinical studies.

• Documented and Reported deficiencies to

management.

• Maintained customer raw material customer specification requirements.

• Check shipments for a wide variety of factors and ensure compliance.

• Inspection of production equipment prior to start up, for change-overs or when handing off to the next shift.

• Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking trending and closure

• Track and Management of deviations, investigations, CAPA in Track wise.

• Actively involved in the investigation review board.

• Processed drug documents and forms for both domestic and international shipments.

• Maintained accurate records and accurately entered patient data into company database in a timely manner.

• Root Cause Analysis- checking if the clinical trials went well and the end client was getting proper drug.

• Complaint Handling- dealing with individual and collective clients regarding prescriptions and medications, investigating and then taking preventive action for the same. See if the physicians are not directly dealing with the client. Employment Gap: Jan 2016 - Jun 2016

• Was looking for the right opportunity

Compliance Analyst /Distribution

Technician Almac Clinical Services -

Souderton, PA June 2010 to December 2015

• Maintain compliance with all current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

• Pick customers' orders to make sure kit list are correct according to the job packs and enter data into MOSES inventory database.

• experience with Supply Chain Coordination of suppliers’ drug inventory

• Maintain stock and inventory to ensure continuity of supply to customer base.

• Drive process improvements to ensure that plant meets or exceeds defined targets.

• Interfaced with quality, manufacturing.

• Achieve best in class performance in all areas of service and cost.

• Root Cause Analysis- make sure the list and the job packs are same and maintain the database.

Inventory and Recall Specialist / QA

Specialist McNeil Pharmaceuticals - Fort

Washington, PA December 2009 to April 2010

• Conducted monthly internal GMP audits as directed by QA Supervisor\Manager.

• Conducted daily walkthroughs of assigned projects.

• Notified Operations Manager and QA Supervisor\Manager of any unusual trends.

• Conducted random checks of inbound receipt for

accuracy.

• Assisted in trending data to look for ways to improve quality processes.

• Made suggestions on quality improvements and facilitate change control process when changes were made to Standard Operating Procedures (SOPs) or Client Work Instructions (CWIs). • Maintained communication with QA Supervisor\Manager supplying reports as requested.

• Maintained the facility programs to ensure that GMP compliance was managed.

Education

High School Diploma North Penn High

School - Lansdale, PA 2006

Skills

• Quality control

• FDA

• Document Control

• ISO

• Quality Assurance

• GMP

• Quality Improvement

• Quality Improvement

Additional Information

Skills Quality Control, Inspection, Quality

Inspector

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