SENIOR MANAGER PLANT QUALITY

PAI Holdings LLC•Greenville, SC

About The 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.

Requirements

Four-year college degree, or equivalent experience resulting in broad knowledge of a field related to the job, such as life sciences, business administration etc., plus 3 years related experience.
And/or training, and 3 years related management experience, or equivalent combination of education and experience.
Intermediate computer skills: MS Office, Alphanumeric Data Entry, Word Processing/Typing
Experience with Warehouse Management System, Statistical Process Control (SPC) systems, Exception and Training tracking systems, Quality Tools systems etc.

Nice To Haves

ASQ Certification a plus

Responsibilities

Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions.
Comprehend, maintain, and promote cGMP and SOP compliance in an FDA/DEA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance standards.
Plan and supervise the daily activities of the quality assurance operation to ensure work is completed in a timely and accurate manner.
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.
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 organization's quality process.
Create and revise SOPs and WIs.
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.