Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary:

Initiate and lead quality investigations in the Lab Operations - Analytical Operations (AO) and Development Operations (DO) including OOS and Unexpected results investigations, and Deviations.

Essential Functions:

• Initiate and lead investigations and authors investigation reports in TrackWise.

• Provide technical leadership on analytical investigations.

• Conduct investigations with input from AO/DO supervisor

• Direct Scientists in the performance of lab investigations.

• Interact with other departments (e.g., PPT, PM, QA), clients and with Subject Matter Experts (SMEs), as required, to thoroughly investigate incidents, conclusions, and appropriate Corrective Action Preventative Actions (CAPA).

• Ensure investigations are ready for approval and completed within required timeframes.

• Provide excellence in data integrity and Good Manufacturing Practice (GMP)/procedural compliance

• Design and facilitate effective CAPA actions. Owns CAPA actions as needed.

• Challenge the department on quality issues and system improvements.

• Maintain a safe working environment and report potential hazards.

• Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

• Bachelor of Science in Chemistry or related science

Experience:

• Minimum 5 years analytical chemistry experience within the pharmaceutical industry

• Previous experience leading a team preferred

• Previous experience in providing client service in the contract pharmaceutical industry

• Previous method validation and product stability testing/reporting experience in the pharmaceutical industry.

• Previous investigation experience in the Good Manufacturing Practices (GMP) analytical laboratory environment.

• Strong interpersonal and communication skills (both oral and written)

• Experience with Technical Writing

Equivalency*:*

• Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities**:**

Exceptional Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge.. Superior problem solving and troubleshooting skills. Ability to carry out investigations in a non-threatening manner with lab operations staff and effectively interacts with internal and external suppliers and clients. Excellent organizational skills with proven ability to prioritize when timeline conflicts exist. Detail oriented. Ability to work well independently and in a team environment. Experience with Microsoft Office Applications. Proficiency in the English Language.