Quality Assurance Manager

Suzan Hopkins

** **. ***** *****, **** Babylon, NY 11704 631-***-**** **********@***.***

Special Skills:

Supervision of 23 employees

Initiation and improvement of Standard Operating Procedures (SOPs)

Assuring policy and procedure compliance

Analyzing complex situations, providing remedial solutions

Hosting FDA and client audits

Internal and External Audits

Initiation and improvement of Master Batch Records

Developing and executing company-wide training

Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Visio; SAP and TrackWise

BS, Chemistry, Hofstra University, Hempstead, NY

CAREER HISTORY

Temporary QC Coordinator, Pall Corp. – 3+ month contract – July 2019 to November 2019

• Reviewed and approved executed batch records

• Revised Standard Operating Procedures (SOPs)

• Inspected and approved/rejected incoming materials including chemicals

• Used SAP for approving batches and incoming materials

Temporary QA Auditor, Emergent BioSolutions – Maryland – 3-month contract – November 2018 to February 2019

• Performed Internal Audits and wrote reports for Quality Assurance, including the Departments of: Training, Facilities &

Maintenance, Document Control, Calibration, Validation, Recalls, Batch Release, Microscopy Laboratory, Deviations,

CAPAs, Complaints and Finished Product Retains

Senior QC Compliance Specialist, Jubilant Cadista Pharmaceuticals, Inc. – Maryland – March 2017 to February 2018 – began as Consultant – hired permanently, worked remotely from New York – manufacturer of solid dosage Rx products

• Revised SOPs

• Investigated and wrote OOS/OOT Investigations and Deviations, including CAPA for the Quality Control Laboratory

• Developed tracking system for investigation and deviation reports to assure they are being addressed and for due dates

to avoid late reports

• Performed Change Control transactions

• Used TrackWise for investigation and deviation reports and Change Control transactions

QA Specialist/Manager, Quality Assurance/Compliance,

Citation Clinical Labeling Systems – February 2013 to January 2017 – manufacturer of labels for clinical studies

• Supervised 18 employees

• Wrote and revised SOPs

• Performed and wrote investigations, including CAPA

• Investigated, wrote and approved Complaints

• Hosted client audits and wrote responses to client audit observations

• Performed internal and external audits according to Good Manufacturing Practices (GMPs) and CFRs

• Wrote deviations

• Improved environmental tracking

• Performed Change Control transactions

• Instituted alternative plan for calibration of equipment, saving approximately $2000 per year

• Wrote, reviewed and approved new equipment Qualification Protocols, and Final Reports

• Developed and performed cGMP training

Quality Assurance Manager, A&Z Pharmaceutical Inc. – September 2010 to February 2012 – manufacturer of solid dosage OTC products – tablets and capsules

• Supervised 12 employees – hired 6 of them

• Assisted with responses to FDA 483s

• Performed internal and external audits according to Good Manufacturing Practices (GMPs) and CFRs

• Reviewed and approved Quality Control Methods

• Wrote, reviewed and approved new equipment Qualification Protocols and Reports, Cleaning and Process Validation

Protocols and Reports, SOPs, Investigations, including CAPA, and Change Control transactions

• Developed and performed cGMP and job specific training

Suzan Hopkins Page 2

Director of Quality Assurance, Syntho Pharmaceuticals, Inc. – May 2007 to August 2007 – manufacturer of solid dosage Rx products

• Supervised two employees

• Wrote responses to FDA 483s

• Developed and performed training for cGMP classes

• Revised Master Batch Records and SOPs

• Interfaced with FDA personnel for audits and information

• Revised Manufacturing Process Validation documentation

• Approved Change Control transactions and Finished Product Specifications

Quality Manager, Aptuit, Inc., formerly Almedica Services Corp – May 2005 to April 2006 – Clinical Packager

• Supervised 23 Quality employees

• Performed internal and external Audits according to Good Manufacturing Practices (GMPs) and CFRs

• Developed and performed training for cGMP classes

• Reviewed and approved Change Control and Deviation reports, including CAPA; Master Batch Records, Component

Specifications and environmental tracking charts

Compliance Manager, Taro Pharmaceutical Laboratories, Inc, - August 2003 to November 2004 – manufacturer of Rx and OTC liquids, ointments and creams.

• Supervised fifteen QA and QC employees

• Wrote SOPs and trained employees on them

• Wrote Master Batch Records

• Performed external vendor audits according to Good Manufacturing Practices (GMPs) and CFRs

• Assisted in FDA audits and FDA 483 responses

• Approved print artwork for tubes, labels, boxes and inserts, reviewing all information according to company/product

requirements and FDA regulations

• Reviewed inserts to assure their accuracy, including indicating incorrect formulas

• Reviewed and approved all documents, including Method Transfer Protocols, Raw Material, Bulk and Finished Product

Specifications, Investigation, Deviation and Incident Reports, including CAPA, Complaints, Annual Product Reviews,

Product Process Validation Protocols and Reports and Equipment Qualification Protocols and Reports and Change

Control transactions

• Facility Supervisor for the New York State Board of Pharmacy

Director of Quality Assurance, Altaire Pharmaceuticals, Inc. October 2002 to March 2003 – manufacturer of Rx and OTC liquids, ointments and creams – also some sterile liquid preparations

• Supervised 17 employees

• Wrote and approved SOPs

• Approved all executed batch records

• Reviewed ANDA submission materials

• Performed internal audits according to Good Manufacturing Practices (GMPs) and CFRs

• Revised Master Batch Records used for manufacturing batches

• Trained employees on Process Validation Protocols

• Reviewed and approved all Change Control transactions, Process Validation Protocols and Final Reports, Methods and

Raw Material, Component and Finished Product Specifications

• Approved all Quality Control, Microbiological and Quality Assurance completed work, including component, raw material

and finished product releases

• Approved print artwork for labels, boxes, inserts and pre-printed containers, reviewing all information according to

company/product and FDA regulations

Senior Quality Assurance Associate, Forest Laboratories, Inc., 1994 to October 2002 – manufacturer of solid dosage – tablets and capsules – and inhaler Rx products.

• Performed Internal and External audits according to Good Manufacturing Practices (GMPs) and CFRs

• Approved investigative reports, including CAPA

• Audited all documents for Research and Development, including batch records, packaging records, laboratory and

stability data for submission to the FDA for product approval

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