Plant Quality Supervisor - 2Nd Shift

GENERAL DESCRIPTION OF POSITION

To plan, organize and supervise the activities of auditing, in-process and finished product inspection in manufacturing and packaging, as well as quality assurance administration, to ensure regulatory compliance, safety, and quality of pharmaceutical products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time.
• Fulfills the essential tasks and responsibilities on a daily basis.
• Comprehend, maintain and promote cGMP and SOP compliance in a FDA/DEA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance standards. This duty is performed daily, about 100% of the time.
• Plan and supervise the daily activities of the quality assurance operation to ensure work is completed in a timely and accurate manner. This duty is performed daily, about 100% of the time.
• Train, coach and mentor QA personnel. Ensure training records are complete and accurate.
• Be proficient in all areas of manufacturing and packaging inspection process, including in-process QA, line inspection, label cage operation, incoming inspections and expiration date assignment. Perform these duties as needed and directed by QA management. T
• Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner.
• Apply a working knowledge of statistical based sampling plans.
• Oversee the Process Issue process. Ensure that the Process Issues Log is maintained.
• Write exception reports and provide information needed to investigate, document and close Exceptions.
• Write, review and participate in investigations as required. Segregate, quarantine and complete documentation for non-conforming materials. Participate in non-compliance and customer complaint investigations.
• Process customer returns and participate in the destruction of material (DOM) process.
• Ensure security of products in controlled substance cages and label control cage. Supervise access to the cages when required to put material into the cages or remove material from cages. Stage additional labeling components from the label control cages as needed.
• Help to identify and lead on-going initiatives for continuous improvements to the organizations quality process.
• Create and revise SOPs and WIs. This duty is performed irregularly, about 10% of the time.
• Support validation activities by ensuring that protocol requirements are being met.
• Provide timely updates to the QA Director.
• Work directly with other departments to provide support for manufacturing and packaging activities.
• Become trained and prepared to handle emergency situations in any department if the need arises.
• Perform any other related duties as required or assigned.

EDUCATION AND EXPERIENCE

Four year college degree, or equivalent experience resulting in broad knowledge of a field related to the job, such as accounting, marketing, business administration, agriculture etc, plus 3 years related experience and/or training, and 3 years related management experience, or equivalent combination of education and experience.

ADDITIONAL INFORMATION

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled