Quality Assurance
Sharon K. Waltrip, RAC
Crestwood, Missouri 63126
636-***-****, cell Email acya6s@r.postjobfree.com
QA Supervisor 2/2/13 – 11/4/2016
Millipore Sigma
St. Louis, MO 63126
QA Supervisor over three sites
Works with site management to ensure maintenance of an effective Quality Management System
Assist and consult as needed with personnel from other sites with Quality Assurance, cGMP compliance, ISO 9001, ISO 13485 guidance
QA Lead on strategic development projects and new customer projects
Conduct CAPA, Complaint and Change Control investigations as part of MRB team
Supervisor batch record review and supplier quality
Develop, review and approve procedures and documentation to facilitate compliance and assist other teams in the development of their documentation
Participated actively on cross-functional support and process improvement teams
Provided leadership, mentorship and coaching for personnel impacting quality, compliance or systems within the Quality Team
Conducted and lead GMP Compliance, ISO 13485 and ISO 9001 audits
Served as ISO 13485, 21 CFR820 and ISO 9001 compliance subject matter expert
Served as quality liaison for logistics between external registrars and Quality group
I resigned my position to commit my time to my pursuit of other opportunities.
Senior QA Project Manager 1/2/12 – 1/18/13
Covidien
675 McDonnell Boulevard
Hazelwood, MO 63042
Worked with Pharmaceutical Sector’s Quality Director and Sector QA Operations Manager to identify multi-plant quality or compliance improvement initiatives
Assisted the Sector Quality Operations group with focused initiatives at specific facilities
Lead strategic quality improvement efforts for projects identified by the Sector Senior Quality Management
Developed project plans and timelines to meet the Division’s objectives and requirements
Independently constructed and executed project plans to achieve desired results with minimal management oversight
Participated actively on cross-functional support and process improvement teams
Provided leadership, mentorship and coaching for activities impacting quality, compliance or systems at the division’s manufacturing facilities
Conducted GMP Compliance audits
Constructed GMP Enhancement plans
Served as GMP compliance subject matter expert
Served as quality liaison for project logistics between division’s Quality Systems groups
I was let go when my position was eliminated in company restructuring and spin-off.
Director of Quality Assurance 9/27/10 – 8/30/11
Synergetics, Inc.
3845 Corporate Centre Drive
O’Fallon, MO
Contact: Kurt Gampp, EVP/COO
■ Responsible for directing the activities of the Quality Assurance, Quality Engineering, Quality Control and Document Control departments including two plants and 30 employees.
■ Responsible for performing the duties of the Management Representative, host all customer and regulatory audits, control the Internal Audit program and ensure the Quality Management System was effective.
■ Responsible for directing the activities of the customer complaint, supplier audit and CAPA programs and ensuring Quality Management System compliance to ISO 13485, UL, FDA and international requirements.
Experienced with Lean/5S programs. Software experience includes Word, Microsoft Access, SAP, Adobe, Excel, and Word Perfect.
I was let go when my position was made redundant in company restructuring.
Self-employed Quality subcontractor:
1/1/1997 – 9/26/2010
Quality Systems
2 Briar Rose Lane
Fenton, MO 63026
Quality Systems is the company I founded in 1997, providing auditing, QSR and ISO 13485 and ISO 9001 Training and Documentation Support Services for a variety of companies maintaining/achieving FDA Quality System Regulation/ ISO Standard compliance.
I subcontracted to Certification Bodies and auditing organizations in the performance of registration, re-assessment, pre-assessment, surveillance, supplier, Medical Device Program Coordination, and GMP audits of companies in a variety of industries and against ISO 9001and ISO 13485 requirements. I subcontracted to the ANAB (National Accreditation Body) as a technical expert during the performance of a witness audit. I subcontracted to course providers and consulted to local companies assisting them with ISO Certification and QMS troubleshooting.
Some of Quality Systems’ clientele subcontracts included:
ISOQAR, Inc.
Contact: Andrew Smith, 866-***-**** Email: isoqarinc.com
AQA, Inc.
Contact: Bart Walrath, 803-***-**** Email: acya6s@r.postjobfree.com
SQA Services, Inc.
Contact: Jennifer Rossel, SQA Program Manager and Ed Snider, Program Manager
310-***-****, www.sqaservices.com
Auditor Training Institute
4803 N. Milwaukee Avenue, Chicago, Illinois, 60630
Contact: Dr. Paul Andre, President, 773-***-****.
Prior to 1997:
Synergetics, Inc. (1994 - 1996) -Medical Device Manufacturer
3845 Corporate Centre Drive, St. Charles, MO, 63304
Contact: Mr. Kurt Gampp, VP, 636-***-****
My position as Director of Quality Assurance and Regulatory Affairs at Synergetics involved the following:
■ Establishing all aspects of the Quality System for the Company to assure compliance with all FDA regulations and requirements.
■ Providing company-wide Quality System and Safety training. Performing all internal and vendor audits.
■ Writing and submitting product pre-market application submissions and FDA registrations/listings on new products, writing all material specifications and SOPs per company system requirements.
■ Dealing directly with the Company President, all Department Heads, all customers for quality and regulatory issues, and all government agencies regarding Quality/Regulatory issues.
■ Control and issuance of all Manufacturing Production Records, Device Master Records, auditing of Production Records, and maintenance of all Production Record History Files.
I worked for the below 3 companies for 6 years. They were at the same location, ownership changed during the time I was there.
Chiron Corp. (Note: this facility of Chiron’s was sold in 1998 to Genetics Institute)
4777 Le Bourget Dr., Berkeley, Mo. 63134 1991 - 1994
My position as a Quality Analyst III at Chiron involved the following:
■ Auditing of all Quality Control assays and procedures. Analytical procedures such as HPLC, spectrophotometry, fluorometry, various protein assays, USP/EP testing.
■ GMP/GLP training for Quality Assurance employees.
■ Stability studies, Validations, composition of SOPs and Validation Protocols, GMP/GLP procedures - writing, editing and training.
■ Responsible for start-up of all quality assurance systems upon buy-out by Chiron.
Centocor – Pharmaceutical Co.
1989 - 1991
Centocor was located at the same facility as Chiron and was sold to Chiron. Centocor was also a pharmaceutical manufacturer and my position at Centocor incorporated the skills mentioned in the above position, as well as the following:
■ Validations of process, equipment and assays, composition of SOPs, GMP/GLP training.
■ Replaced manager during her maternity leave, was responsible for two other analysts and reported directly to the Director of QC/QA.
Invitron – Pharmaceutical Co.
1988 - 1989
Invitron was also located at the same facility as Chiron and was sold to Centocor in 1989. Invitron was a contract manufacturer of pharmaceutical products and all skills listed above under Centocor and Chiron were incorporated, as well as the following:
■ Wrote and performed all research for an article published in the scientific journal, BIO/TECHNOLOGY, 4/89, entitled "The Detection and Quantitation of DNA Contamination in Experimental Bioreactors". My last name at the time was McKnabb.
■ Responsible for assisting the supervisor in a Lead Analyst Role.
■ Researched and developed assays and products.
Education:
Board Certified in Medical Technology, ASCP, 1983. Elected to Outstanding College Students of America in 1987. Bachelors’ degree in Biology received in 6/88 from North Central College in Naperville, Illinois. Graduated Cum Laude. Received Tri-Beta Biological Honor Society Membership. Course work completed towards M.S. in Environmental Science at S.I.U.E. in 1989. Regulatory Affairs Certified, 1996. ISO 9000, QMS-LA (Lead Auditor) Certification training course completed May, 1997, QMS-A in 1998, QMS-LA received in 1999.
Work experience prior to 1988 involved Quality Assurance and System Establishment in Clinical Laboratory settings, included management experience and is available upon request.
ADDITIONAL REFERENCES AVAILABLE UPON REQUEST AND BELOW
Letter of Recommendation for Ms. Sharon Waltrip
I have known Ms. Waltrip over the course of a number of years first in her capacity as an independent auditor for Quality Control and Quality Assurance in the area of manufacturing of medical devices and secondly in her capacity as Director of QA/QC at Synergetics USA, Inc. In both capacities her knowledge of the regulations and her ability to refine and perfect quality systems was outstanding. In both areas Ms. Waltrip was able to discover any areas of nonconformity but moreover was able to demonstrate and instruct those responsible on how to improve and correct any deficiencies. In her capacity at Synergetics she was able to work with and establish a rapport with outside auditors from various agencies and always come to a satisfactory audit conclusion.
In my thirty years of experience in the medical device industry I have almost never come in contact with anyone more knowledge or more capable in the area of QA/QC than Ms. Waltrip and I would most highly recommend her for any position in this area.
Jerry L. Malis, M.D.
Executive Vice President and Chief Scientific Officer
Synergetics USA, Inc.
484-***-****, Synergetics, Inc., 610-***-****, mobile
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