SUPERVISOR - QUALITY ASSURANCE

Biotechnology Company

Pharmaceutical Manufacturing

8 years of pharmaceutical or related experience in Quality Assurance required.

POSITION SUMMARY

The Supervisor, QA Manufacturing carries out supervisory responsibilities in accordance with the organization’s policies, procedures, and state, federal, and local laws. Under general supervision, coordinates and directs the quality assurance functions of the Quality Assurance Inspectors. The incumbent will assure individual compliance with the DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and company policies and procedures.

ESSENTIAL FUNCTIONS

·         Oversees, supervises, coordinates and prioritizes the daily activities of the Quality Assurance Manufacturing Department.

·         Assures completion of inspection and suits of lots at the incoming, in-process and packaging areas to ensure compliance with cGMP and SOPs.

·         Performs review and disposition of process/product deviation investigation reports, ensuring all deviations are thoroughly investigated, documented, and that proper corrective action is taken.

·         Performs Quality Operations review/approval of Standard Operating Procedures (SOP), Document Change Requests (DCR), Change Controls, and Work Orders.

·         Interfaces with all other quality groups within the company on quality systems issues.

·         Works with Plant Operations to ensure compliance with and understanding of cGMPs, SOPs, and FDA s

·         Assists with FDA and other regulatory agency audits and inspections.

·         Participates in the department budget process and operates within established budget.

·         Oversees, participates and approves the interviewing, hiring and training of departmental employees; and conducts performance evaluation for direct reports.

·         Provides support, direction and coaching to subordinate employees in the areas of training, disciplinary action, problem solving, planning and work assignment delegation.

·         Ensures project deadlines and performance standards are established and met.

EDUCATION/EXPERIENCE REQUIREMENTS

·         Requires a Bachelors degree in Chemistry or the Life Sciences from an accredited college or university with a minimum of 8 years related experience in Quality Assurance, preferably in a pharmaceutical environment.

·         An equivalent combination of education, experience and training may substitute.

·         Quality Control/Assurance sampling techniques.

·         Labeling processes and techniques in the pharmaceutical industry.

·         Ability to aseptically gown