Oversaw a staff of 14 working in both Quality Control and Quality Assurance.• Redeveloped the Supplier Qualification Program, identifying and remediated shortfalls of previous program.• Responded to customer audit findings by completing Root Cause Investigations and developing Corrective Action Plans.• Provided quality oversight in weekly project meetings.• Drafted Quality Agreements for contract manufacturers and performed final Quality reviews.

Responsible for providing quality oversight of the Quality Control laboratories.• Reviewed and approved laboratory deviations, procedural changes and instrument qualifications.• Assisted with the Annual Product Review process.

Worked directly with the Quality leadership team to provide additional resources in needed areas.• Reduced the laboratory investigation turnaround time by 40%.• Conceptualized QC key performance indicators and presented information monthly to the site management team.

Oversaw department of 50–65 with 5-10 direct reports including Managers, Scientists and technical support functions.• Developed a technical transfer plan for the addition of a new QC testing site within the company.• Ensured constant state of laboratory compliance demonstrated by two FDA audits with zero 483 observations.• Managed a department budget of approximately $8M

Oversaw a staff of 20-30 including 5-10 direct reports including Supervisors and Senior Scientists over 3 shifts.• Streamlined the lab investigation process by performing preliminary review of findings prior to final QA review.• Oversaw transition to a 24/7 operation. Developed and maintained the rotating management on call schedule to provide support to those working off shifts.• Approved Purchase Orders and maintained compliance with the laboratory operations budget.

Oversaw a staff of 6-12 direct reports who were responsible for the execution of stability and raw material testing.• Managed an outside laboratory testing budget of more than $200,000.• Authored laboratory investigations, performed root cause determination and implemented appropriate corrective and preventative actions.• Represented the QC department in regulatory audits as well as marketing partner audits.• Designed training matrices to track employee growth.• Authored and revised SOPs, Work Instructions, and Test Methods

Assumed positions of increasing responsibility, performing testing of raw material, batch release, and stability samples • Developed into subject-matter expert for the analysis of the firm’s specialty injectable oncology drug.• Assisted Laboratory Management and Technical Services Departments during investigations and deviations.• Trained and mentored new employees.• Performed method transfers. Was responsible for the transfer of 8 different cleaning verification methods.• Skilled in the operation and maintenance of Agilent 1100 and 1200 HPLC’s

• Routine testing on components, raw materials, batch release, and stability samples.• Performed method transfers into the QC laboratory.• Reviewed peer's data for accuracy and thoroughness.• Assisted in the training on new employees.

Performed routine quality control testing on components, raw materials, batch release, and stability samples.

Conducted chemical tests on raw materials and finished product pharmaceuticals in an FDA and DEA licensed GMP laboratory.• Conducted classical wet chemistry testing, FTIR and USP dissolution.• Performed tests from the USP/NF, FCC, JP, Ph. Eur. and ACS.• Ensured all tested was completed in a timely manner so that results were accurate and thorough and met all customer requests.