SUMMARY:

A local manufacturing/packaging company is looking for a Quality Manager. The Quality Manager will work closely with the Director of Quality and Regulatory Affairs and all other 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:

§ Supervise and offer leadership to employees in accordance with policies and guidelines.

§ 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.

§ Handle Customer Complaints, including: logging, tracking, investigating, and responding back to the customer. 

§ Participate in regulatory and customer audits.

§ Ensure compliance GMP, FDA, OSHA, 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.

§ Minimum 3 years’ experience in an FDA facility.

§ Prior experience in a pharmaceutical manufacturing facility.

§ Knowledge of GMP, ISO 9000, and FDA requirements.

§ Proven experience implementing and managing quality systems in a GMP environment.

§ Auditing certification preferred.

§ ASQ certification preferred.

§ Prior supervisory experience.

§ 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 20 pounds.

§ Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.