Manager, QC Compliance

Summary
A Quality Control Lab Compliance Manager is responsible for ensuring that laboratory operations adhere to regulatory standards and maintain high-quality outputs. The role involves conducting internal lab audits to ensure compliance with key quality attributes, including equipment qualification, technology transfers, training competencies, data accuracy, and data integrity. The manager should have strong knowledge of Quality Management systems and experience in investigating non-conformance and leading corrective/preventive actions. Proficiency in technical writing is essential for drafting procedures, reports, protocols, and investigations.

Responsibilities

• Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage stability and sample receipt programs.
• Review equipment logbooks, audit trails, and preventive maintenance and calibration of equipment.
• Collaborate with multiple groups to author/review URS, SLIA, and qualification protocols.
• Investigate and resolve compliance issues, including OOS and deviations. Initiate change controls and implement CAPA as needed.
• Perform regular audits and inspections of laboratory practices and documentation to ensure compliance with regulatory standards.
• Lead protocol/report writing and training associated with technology transfer. Support the execution in coordination with Lab Managers.
• Review and maintain training records for the department. Identify training needs and design programs to enhance staff competency.
• Lead and train a team of lab compliance officers and technicians.
• Stay updated on industry regulations and ensure compliance with all relevant laws and standards.
• Review and analyze data related to lab operations and compliance to identify trends and areas for improvement. Prepare detailed reports on lab compliance activities.
• Perform other duties as assigned.

Qualifications

• Education: A bachelor's degree in Chemistry, Biochemistry, Biotechnology, or a related discipline. Advanced degrees may be preferred.
• Experience: 5-7 years of lab experience in analytical method development, validation, and technology transfer in the biopharmaceutical industry. 1-3 years of investigation and audit experience.
• Skills: Proficiency in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, and other analytical methods. Skilled in LIMS/Veeva/TrackWise/Master Control.
• Communication: Exceptional verbal, written, and interpersonal communication skills. Comfortable in a multi-cultural environment, able to communicate activity status to Quality Assurance leadership and explain the application of cGMP regulations.

Physical Demands

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.
• This job functions in an open office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.
• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.
• Enter additional specific physical requirements needed for this role.
• Must be able to sit and stand for an entire shift and will usually remain in a stationary position throughout the shift.
• Will use repetitive motion of the hands, wrists, or fingers, such as typing.
• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work
• This job operates in an office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets

Salary Range: $94,000 to $131,000 annually

Benefits:

• Health Insurance Medical, Dental, Vision
• Life and AD&D Insurance
• Disability Insurance
• 401k Retirement Plan
• Paid Time Off (Vacation, Sick Leave, Holidays)