QC Manager (Chemistry Lab)

Job Location: Oceanside, CA
Job Description:
The QC manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 GMP operations to ensure compliance with regulatory requirements and managing the quality control functional group. The QC manager will interact with customers to respond to their question/concerns/needs of analytical services including but not limited to stability studies, method development and/or transfer. The
Quality Control team is responsible for all analytical activities associated with the support of manufacturing activities, including raw material testing. The QC manager is responsible to foresee the QC workload trend and plan adequately to respond to the increasing demand for QC services.

Specific Duties and Responsibilities:

• Maintain and coordinate the operation of the Quality Control laboratory on a day to day basis.
• Conduct and/or oversee the analytical methods validations.
• Participation in completing cleaning validation and revalidation activities.
• Establish stability studies protocols and test method as needed.
• Oversee the final product testing and release according to the corresponding approved SOPs.
• Establish raw material and final products specifications as necessary
• Oversee raw material and final products testing and release according to approved procedures.
• Write standard operating procedures, standard testing procedures and other related GMP documents including QC reports.
• Oversee the training of the QC personnel.
• Investigate deviations and out of specification results.
• Take part in customer and/or suppliers audits as subject matter expert.
• Interact with customers in response to customers’ needs for method transfer and/or development.
• Recruitment and training of QC personnel.
• Ensure the Safety Guidelines set forth by the company are followed in the QC lab.

Requirements:

• Bachelor’s degree in Chemistry, Biochemistry or closely related scientific discipline with 3-5 years in a laboratory environment including experience with analytical equipment (e.g.: HPLC, UPLC, GC, MS, GC, KF, FTIR).
• Experience working in a regulated environment (e.g.: ISO, ICH GMP), preferred. Experience with analytical methods development and validation.
• Experience with equipment calibrations, maintenance and qualifications.
• Proven ability to lead, coach, and motivate employees.
• Two years in a management position preferred.
• Experience in project management is a plus.

Job Type: Full-time

Salary: $143,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $143,000 - $145,000