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QA QC Resume

Desired Industry: Biotech SpiderID: 59644
Desired Job Location: Lancaster, Pennsylvania Date Posted: 4/19/2012
Type of Position: Full-Time Permanent Availability Date: 2 week
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: No

I bring over 14 years of experience within the pharmaceutical industry, including 10 years in Quality Assurance. I possess a strong cGMP background, with experience in multiple aspects of quality, including significant experience in documentation and analytical data review. I have a firm understanding for the necessity of compliant documentation, and possess a strong attention to detail.

I was a key member in developing and maintaining an internal deviation and CAPA Program at SAFC. I was a primary resource for ensuring complete and thorough investigations and developing appropriate corrective/preventative action plans, and following-up to meet commitment deadlines.

In addition to performing internal audits, I was the primary contact and host for customer audits. I have also participated directly in FDA inspections. With regard to external audits, I was implemental in crafting appropriate responses, and following up on observations.

I provided regular cGMP training to site personnel as well as mentoring quality professionals that reported to me.

I am a self-motivated problem solver with an ability to adapt to new situations, as well as a team oriented professional with excellent interpersonal skills.

•Managed multi-shift QA Finished Product personnel (4-8) and all aspects of daily operations to be compliant with cGMPs, company policies and client requirements.
• Led client complaint and material review boards. Assisted in Root Cause Analysis, trending and CAPA of deviations.
• Participated in process improvement teams to improve quality in site processes and streamline activities
• Provided guidance and final QA approval for site SOPs, Validation Protocols, Batch Record Review and product release.

Framingham State College, Food Science, BS
University of Massachusetts, Zoology


Experience in GC, HPLC, UV, automated dissolution.
Experienced in Microsoft office, Power Point, BPCS, SAP
Experienced in SOP, Validation, Technical Transfer, Audit reports
cGMP training of site personnel

Additional Information:
“Meeting the Gas Chromatographic Retention Time Stability Requirements for Pesticide Analysis in the EPA 3/90 Statement of Work”, Poster Achievement Session, Lancaster Laboratories, April 30, 1993, Co-Author.

“The Variation of Sonic Plesio-Velocity in Dose Dependent Lathyritic Rabbit Femurs”, Sidney Lees, Steven M. Barnard and Donna Churchill, Ultrasound in Medicine & Biology, Vol. 13, No. 1, pp 19-24, Bioengineering Department, Forsyth Dental Center, 140 Fenway, Boston, MA 02115 U.S.A., 8 May 1986

Available upon request.

Candidate Contact Information: has chosen not to make contact information available on this page.
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