Benefits: All Silgan Unicep employees are eligible to participate in our dental, medical and/or vision benefits after a probationary waiting period.
- 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.
- 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 Quality Management System. Ensure compliance of system and enforce adherence to change control and related processes maintained by the system.
- Administer the calibration program. Ensure that equipment is maintained in a calibrated state compliant with applicable regulatory requirements.
- Administer the validation program. Ensure that equipment, processes, etc. are validated in accordance with applicable guidance for industry and regulatory requirements to ensure reproducible and consistent product quality.
- Administer the Corrective and Preventive Action (CAPA) program and Deviation and Nonconforming (NCR) programs against defined parameters. Ensure that CAPAs, Deviations and NCRs 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.
- Participate in 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.
- Assists with updating and creating SOPs and Work Instructions within pertinent areas of responsibility.
- 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.
- Other duties as assigned.
- Bachelor’s degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
- Minimum 5 years’ experience in a Quality Assurance leadership capacity.
- Minimum 3 years’ experience in an FDA facility.
- Experience handling customer complaints, CAPAs, NCRs, and Deviations.
- Prior experience in a pharmaceutical manufacturing facility.
- Knowledge of GMP, ISO 13485, ICH Guidance, and FDA requirements.
- Proven experience implementing and managing quality systems in a GMP environment.
- Auditing certification preferred.
- Prior supervisory experience.
- Proficient with Microsoft Office products, including Word and Excel.
- 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.