Quality Control Supervisor

Scope and Purpose of Position

Schedule and supervise Quality Control activities related to chemistry testing and for all product lines. Represent the chemistry laboratory at internal/external meetings and during audits. Act as direct supervisor to all chemistry staff. Functions as a site subject matter expert (SME) for analytical chemistry, including raw materials, drug product release and stability testing.

Responsibilities

1. Oversee and delegate the necessary testing in the chemistry lab.

2. Ensure QC release testing and stability program are executed per SOP's and support investigations and CAPAs.

3. Provide leadership, development and direction to the chemistry laboratory staff.

4. Support the hiring of Laboratories staff that is technically capable to carry out the related job duties.

5. Support regulatory inspection and customer audit activities. Support all regulatory submissions of the customers.

6. Collaborate with technical group in transfer of new products, processes and test methods from customer.

7. Identify process and quality problems, recommend solutions, develop or recommend process improvements, and assist with implementation.

8. Interact with customers on contract test services provided by the chemistry laboratory.

9. Interact with contract laboratories on contract test services for the chemistry laboratory.

10. Write, revise, review and approve documentation related to test method validation/verification and routine testing.

11. Acquire and qualify new equipment for chemical and physical testing.

12. Review and verify test results from both in-house and contract laboratories (as needed).

13. Support completion of urgent activities through hands-on test execution (as needed).

Required Knowledge, Skills and Abilities

• Must have strong communication, leadership, and interpersonal skills.
• Ability to coordinate multiple responsibilities and activities simultaneously.
• Must be comfortable working in a dynamic environment with changing priorities.
• Excellent knowledge of analytical test methodologies.
• Strong technical and problem-solving skills in the areas of chemical testing.
• Understand the GMP requirements for the pharmaceutical industry, with Quality Control/compliance background (preferred).
• Strong skills dealing with the FDA and/or ISO/ICH (preferred).

Required Education and Experience

• Bachelor or Advanced Degree in Chemistry
• 5+ years of related experience
• Experience leading or supervising a team.

Salary Range - $95,000 - $115.000

Job Type: Full-time

Pay: $95,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Irvine, CA 92618: Relocate before starting work (Required)

Work Location: In person