Quality Assurance Supervisor

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.

1. Fulfills the essential tasks and responsibilities on a daily basis. 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.
This duty is performed daily, about 100% of the time.

2. 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. This duty is performed daily, about
100% of the time.

3. 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. This duty is
performed daily, about 100% of the time.

4. Train, coach and mentor QA personnel. Ensure training records are complete and accurate. This duty is
performed daily, and about 100% of the time. This duty is performed daily, about 100% of the time.

5. 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. This duty is performed daily, about 100% of
the time. This duty is performed daily, about 100% of the time.

6. Review batch records for accuracy and completeness for product disposition. Ensure that corrections
are made in a timely manner. This duty is performed weekly, about 50% of the time. This duty is
performed weekly, about 50% of the time.

7. Apply a working knowledge of statistical based sampling plans. This duty is performed weekly, about
50% of the time. This duty is performed weekly, about 50% of the time.

8. Oversee the Process Issue process. Ensure that the Process Issues Log is maintained. This duty is
performed weekly, about 50% of the time. This duty is performed weekly, about 50% of the time.

9. Write exception reports and provide information needed to investigate, document and close Exceptions.
This duty is performed weekly, about 50% of the time. This duty is performed weekly, about 50% of
the time.

10. 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. This duty is performed monthly, about 25% of the time. This duty is performed
monthly, about 25% of the time.

11. Process customer returns and participate in the destruction of material (DOM) process. This duty is
performed monthly, about 25% of the time. This duty is performed monthly, about 25% of the time.

12. 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. This duty is performed weekly, about 20%
of the time. This duty is performed weekly, about 20% of the time.

13. Help to identify and lead on-going initiatives for continuous improvements to the organizations quality
process. This duty is performed daily, about 100% of the time. This duty is performed daily, about
100% of the time.

14. Create and revise SOPs and WIs. This duty is performed irregularly, about 10% of the time. This duty
is performed irregularly, about 10% of the time.

15. Support validation activities by ensuring that protocol requirements are being met. This duty is
performed weekly, about 25% of the time. This duty is performed weekly, about 25% of the time.

16. Provide timely updates to the QA Director. This duty is performed daily, about 20% of the time. This
duty is performed daily, about 20% of the time.

17. Work directly with other departments to provide support for manufacturing and packaging activities.
This duty is performed daily, about 100% of the time. This duty is performed daily, about 100% of the
time.

18. Become trained and prepared to handle emergency situations in any department if the need arises. This
duty is performed irregularly, about 10% of the time.

19. Perform any other related duties as required or assigned.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty mentioned
satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability
required.

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.

SUPERVISORY RESPONSIBILITIES
Supervises 3-8 non-supervisory employee(s). Carries out supervisory responsibilities in accordance with the organizations
policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning,
assigning and directing work; appraising performance, rewarding and disciplining employees; addressing
complaints and resolving problems.

COMMUNICATION SKILLS
Ability to effectively communicate information and respond to questions in person-to-person and small group
situations with customers, clients, general public and other employees of the organization.

MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of
plane, algebra, solid geometry and trigonometry.

PREFERRED CERTIFICATES, LICENSES, REGISTRATIONS
ASQ Certifications

SOFTWARE SKILLS REQUIRED
Intermediate: Alphanumeric Data Entry, Database, Spreadsheet, Word Processing/Typing
Basic: Other, Payroll Systems, Presentation/PowerPoint

ADDITIONAL SOFTWARE SKILLS
Warehouse Management System, Statistical Process Control (SPC) systems, Exception and Training tracking
systems, Quality Tools systems

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