Analytical Laboratory Manager

JOB DESCRIPTION
Responsible for the management and operation of the Quality Ccontrol laboratory under the direction of the Quality Control
Director. Responsible for the testing of raw materials, bulk and finished products, and stability samples in a
manner that ensures the quality of products and meets all compliance and DEA requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES
1. 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.
2. Organization, management, supervision, and training of laboratory personnel. Provide supervision and
training to the administrative staff. Ensure that department training requirements are met and that the team
possesses a sufficient skill set to achieve objectives.
3. Responsible for the inspection of received raw materials, selected packaging materials, and laboratory
supplies to include vendor corrective action and documentation as needed.
4. Responsible for disposition of final product for release.
5. Direct laboratory investigations (LIRs) and ensure completion in a timely manner. Monitor trends in
laboratory investigations and enforce preventative action.
6. Establishment and maintenance of procedures and record keeping systems required for the laboratory to
be in compliance with CGMPs, EPA and OSHA regulations.
7. Overall responsibility of raw material, bulk, and finished product specifications and compliance thereof.
8. Cost control and productivity in the laboratory and other quality control areas.
9. Assist chemists in assay development and validation.
10. Assist in process/method qualifications and process validations.
11. Maintaining GMP practices in all areas of responsibility.
12. Participate in both internal and external audits, includes preparing audit responses and overseeing
corrective actions identified are implemented.
13. Perform personnel evaluations and performance reviews.
14. Manage and resolve employee conflicts and enhance morale.
15. Develop and implement new and revised SOPs to ensure compliance with USP updates and cGMP
guidelines.
16. Troubleshoot problems and work to resolve issues with laboratory instruments and analytical equipment.
17. Accountable for quality control compliance with recognized regulations.
Perform any other related duties as required or assigned.

QUALIFICATIONS
5+ years of supervisory experience in a pharmaceutical lab environment required.

EDUCATION AND EXPERIENCE
Five year technical degree (I.E. bachel ors) or equivalent experience required. In such fields such as engineering,
science, computer engineering, etc, plus 9 to 10 years related experience and/or training. Or equivalent
combination of education and experience.

SOFTWARE SKILLS REQUIRED
Advanced: Word Processing/Typing
Intermediate: Payroll Systems, Sprea dsheet
Basic: Database, Presentation/PowerPoint

ENVIRONMENTAL CONDITIONS
The following work environment charac teristics described here are representative of those an employee
encounters while performing essential functions of this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
While performing the functions of this job, the employee is occasionally exposed to toxic or caustic chemicals.
The noise level in the work environment is usually moderate.

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