We seek a highly motivated Sr. Manager/Manager of Quality Control to join our Operations team. QC Manager will be responsible for planning, scheduling, and evaluating production QC activities for commercial products. QC Manager will also manage QC activities of new product transfer from the product development group and product stability program, as well as maintain the QC practices compliance to ISO 13485/GMP requirements.

Duties and Responsibilities

• Plan, schedule, and supervise routine QC activities of the QC staff. Manage the priorities in accordance with weekly MFG/QC planning meeting.
• Review incoming raw materials QC records as well as analytical and functional testing reports for product release.
• Write, revise, and review QC SOPs, incoming Raw Material QC Spec and other Good Manufacturing Practices (GMP) documentation.
• Establish a system for managing test samples, reagents, and reference standards. Ensure QC laboratory compliance to established specifications and procedures.
• Manage real time stability program for commercial products.
• Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
• Identify discrepancies, participate in quality investigations and CAPA initiatives as needed. Assure the implementation of appropriate and timely corrective actions.
• Perform analytical and functional testing of routine and non-routine samples and document according to GMP/or ISO 13485 standard. Collect, analyze and interpret QC data.
• Ensure QC equipment is maintained in a qualified state.
• Follow all established laboratory, regulatory, safety, and environmental procedures.
• Perform other duties as assigned.

Qualifications:

• A BS/MS in molecular biology, biochemistry or related field with at least 10 years of laboratory experience of which 2 years in supervisory role
• Experience in molecular biology techniques. Hands-on experience in antibody conjugation, immunoassays (e.g. ELISA) and PCR is preferred.
• Experience in setting up and maintaining QC laboratory practices compliance to ISO/GMP requirements. Experience in quality audit is a plus.
• Experienced leader and people manager with proven ability in developing staff to maximize contributions to department and company.
• Demonstrated ability to navigate through ambiguity with strong problem-solving skills.
• Ability in finding opportunities and implementing of new technologies and services to facilitate an efficient and effective organization
• Ability to multi-task and prioritize work assignments with little supervision.
• Excellent organization and analytical skills.
• Excellent verbal and written communication skills.