Job Title: Quality Supervisor
Location: Irwindale, CA
Duration: Permanent
Environment: Onsite
Hours: Monday- Friday; 8am-5pm
Salary: up to $70,000 (depending on experience)

Reporting to the Director of Quality, the Plant Quality Supervisor will lead a team of Quality Assurance associates or technicians working directly with production and operations to ensure raw materials and components are sampled, controlled, and released to production when specifications are met or quarantined as necessary. Partners with operations to ensure quality investigations are thoroughly performed, provides quality support to the manufacturing process, ensures timely review and approval of final product batch documentation, and ensures products are manufactured in compliance with site, regulatory and GMP guidelines.

Key Role Specific Requirements:

• Provide on the floor QA oversight and support to ensure compliance to procedures and GMP guidelines throughout the facility

• Ensure approval and timely release of raw materials, components, and final product. Escalates to management in the event of delays or related non-conformances.

• Review and approve executed batch records against procedures, GDPs and regulatory compliance

• Compile and verify all batch related documents into a final product lot disposition package

• Lead and partner with operations to ensure manufacturing deviations, batch discrepancies, or out-of-specification events are evaluated for product impact, investigated thoroughly to determine accurate root cause(s) and appropriate corrective and preventative actions and reports are documented thoroughly.

• Participates in preparing for and hosting facility audits by customers, regulators (such as FDA, HPRA and Health Canada) including responding to corrective actions and/or observations as required.

• Promotes and advocates quality achievement and performance improvement across the organization

• Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation

• Creates trainings on various GMP related topics and conducts trainings as needed.

• Ensures safety of staff through training, policies, procedures, and support of the JHSC meetings, inspections and initiatives.

• Monitors department and company quality systems and advises management on team performance. Publishes metrics regarding performance against set goals and makes recommendations.

• Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.

• Achieves results through direct reports by communicating job expectations and company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.

Essential:

• 3-5 years relevant experience in a regulated pharmaceutical industry including Quality Assurance, Quality Control with 2 of those years being in a leadership role.

• BSc degree in science or related field

• Knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing, and packaging processes.

• Must possess leadership qualities to be able to comfortable and successfully interface and communicate with all levels internally and externally.

• Detail oriented with strong collaboration skills

• Ability to prioritize critical tasks

• Ability to read, write and communicate expertly in English

Desirable:

• BSc degree in quality management

• 5-7 years’ experience in a cGMP environment

• Knowledge of process validation

• Experience in aseptic manufacturing facility