Senior Quality Control Manager

The Senior Quality Control Manager works closely with all Department Managers to assure there is consistent quality of production by enforcing good manufacturing practice systems; overseeing day-to-day compliance activities, auditing processes; providing documentation, and managing staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate with the Leadership Team to drive for achievement of company KPIs and initiatives.

• Provide leadership by building, motivating, and directing cross-functional teams to meet company strategic goals. Responsible for driving adherence to company Quality standards and policies.
• Supervise and offer leadership to managers and employees in accordance with policies and guidelines; including mentoring, training, evaluating, and motivating employees to meet company and department goals.
• Interview, hire, and train employees, plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints, and resolve problems as needed.
• Identify quality-related training needs and deliver training throughout the company.
• Assist with the quality management strategy and assist in setting policy, quality goals, and milestones.
• Participate in change and problem-solving teams; be an agent for compliant change.
• Administer the Corrective and Preventive Action (CAPA) program and Deviation and Nonconforming (NCR) programs against defined parameters. Ensure that CAPAs, Deviations and NCR's are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, risk mitigation, and verification of effectiveness of the plan. Log, track, and ensure that the CAPA, Deviation and NCR procedures are maintained in a compliant state.
• Administer Nonconformance system. Ensure that nonconformances are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Nonconformance procedure is maintained in a compliant state.
• Administer the Deviation system. Ensure that deviations are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Deviation procedure is maintained in a compliant state.
• Administer the Internal Audit Program. Ensure procedures are maintained, training is provided for internal auditors, annual audits scheduled, and responsibilities assigned to audit team. Coordinate the generation of corrective actions for audit findings and ensure follow up from responsible parties.
• Analyze audit data and prepare reports for management review and continuous improvement initiatives.
• Oversee Customer Complaints, providing direction and accountability for timely review, investigation, and response.
• Participate in regulatory and customer audits.
• Ensure compliance GMP, FDA, OSHA, ISO 13485, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
• Minimum 5 years’ experience providing GMP regulatory compliance in Manufacturing or Quality Assurance for Cosmetics, OTC Drugs, Medical Devices, or similar industry.
• Minimum 3 years’ experience in an FDA facility.
• Prior experience in a pharmaceutical manufacturing facility.
• Knowledge of GMP, ISO 13485, and FDA requirements for Foods, Drugs, and Medical Devices.
• Proven experience implementing and managing quality systems in a GMP environment.
• Auditing certification preferred.
• ASQ certification preferred.
• Prior supervisory experience required.
• Excellent communication skills, both verbal and written.
• Excellent analytical and problem solving skills.
• Strong leadership skills.
• Proficient with Microsoft Office products, including Word and Excel.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established timelines.
• Excellent attention to detail and good organizational skills.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to  25 pounds (12 kg).
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Salary : $95,000 - $105,000 (exempt)

LIMITATIONS AND DISCLAIMER