Quality Control Team Lead – Finished Products

Duties and Responsibilities:

• Prioritizing and executing daily Quality Control data review of finished materials.

• Ensure prompt review of documentation of Finished Products release and stability studies.

• Ensure Quality System, cGMP and ICH guidelines are followed.

• Interface with production and Quality Control to achieve an effective finished product release.

• Maintain testing time to plant schedule for production use. Maintain lean and efficient testing process and metrics. Maintain reliable testing equipment.

• Shows process deviations and proposes process change controls when necessary.

• May write and develop Standard Operating Procedures (SOP’s), specifications, protocols, and reports.

• Perform root causes for deviations and propose effective CAPAs (corrective and preventive actions).

• Developing and executing training plans for new hires.

• Handles keeping high safety, housekeeping, and cleanliness standards.

• Mentor and/or lead other Quality Control chemists.

• Participate in customer calls and respond to customer emails as needed.

• Track finished product reference standards monthly to ensure retest dates are up to date and set up new reference standards.

• Performs all other duties as needed for this position.

Qualifications:

• Bachelor’s degree in chemistry, biochemistry, or other related field in life sciences.

• 1 – 3 years of supervisory experience in a GMP (Good Manufacturing Practices) laboratory environment.
• In-depth knowledge of GMP regulations and Quality Control principles.
• Strong leadership and interpersonal skills.
• Effective communication and problem-solving abilities.
• Attention to detail and commitment to supporting high-quality standards.
• Familiarity with relevant industry regulations and standards.

Salary: $75K-$85K annually

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.