QA QC - Biotech Resume Search
QA QC - Biotech Resume Search
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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


Objective:
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.



Experience:
•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.


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


Affiliations:
ASQ


Skills:
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:
Presentations
“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.

Publications
“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


Reference:
Available upon request.


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