Quality Assurance Control

Location:

Posted:

August 27, 2014

Jamesa Nicholson

Analytical Scientist

Durham, NC

*********@*****.*** - 248-***-****

To provide quality control support functions within a professional organization that will focus on cGMP/GDP

compliance to established quality assurance processes and standards for manufacturing and packaging.

WORK EXPERIENCE

Analytical Scientist

Pfizer - Groton, CT - November 2006 to March 2014

Provided cGMP analytical support to stability, drug release, and in-process testing for API disposition

• Performed analytical techniques including HPLC, LC/MS, Dissolution, Disintegration, water KF, and FTIR

• Trained staff on GLP analytical techniques and GMP equipment

• Tracked and trended quality systems ( CAPA, LIMS, Empower, Trackwise, Clementine, eNotebook)

• Performed AMTE's

• Reviewed and approved laboratory data for manufacturing and packaging batch record release

• Performed protocols to facilitate changes to SOP's/SOI's and training documents

• Prioritized projects to meet targets and timelines for disposition

• Provided and tracked metrics for internal and contract vendor support test functions

• Coordinated documentation and testing parameters to contract vendors

• Notified QA management of quality/compliance issues and trends

Technical Scientist

Pfizer - Ann Arbor, MI - November 2003 to October 2006

Supported inventory management processes

• Performed Safety Lab Inspections

• Approved ATP protocol for Titian Software

• Assisted internal customers with compound ordering

• Operated automated liquid handler and neat compound weigher to fulfill sample requests

• Interacted with SPS functions to complete daily transactions for neat and solvated sample requests

• Retrieved and weighed out chemical compounds for analytical and clinical research

• Problem solved errors pertaining to chemical submission and storage maintenance

ATTRIBUTES:

• Proficient in Microsoft Word, Excel, Power Point, Outlook

• Exhibit advanced analytical thinking and troubleshooting skills

• Attention to detail and good documentation practices

• Demonstrated ability to multitask, meet deadlines and work in cross-functional teams

EDUCATION

B.S. in Human Biology

Michigan State University - East Lansing, MI