Supervisor, Quality Assurance

JOB TITLE : SUPERVISOR, QUALITY ASSURANCE

 

JOB PURPOSE: Supervises a staff of QA analysts, inspectors and technicians to ensure that raw materials in process materials,

finished products and packaging and ensure they are in compliance with chemical, biological, microbiological

and/or physical quality control programs and external regulations.

 

JOB ACCOUNTABILITIES :

• Regular and predictable onsite attendance and punctuality.
• Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned
• personnel, and when required assist other Quality areas in the successful performance of these activities.
• Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and
• timely manner.
• Be directly involved in and where appropriate lead multiple process/product improvement projects which may include, Lean Manufacturing or other focus groups, design of experiments, validation protocols.
• Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, DEA and company quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements.
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
• Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
• Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
• Assists and writes validations for equipment, product changes and computer systems.
• Assists with vendor audits/assessments and provides ongoing feedback related to quality issues

 

QUALIFICATIONS:

Minimum: College graduate (BS in Chemistry, Biology, Pharmacy or Related science)

 

EXPERIENCE

Minimum: Up to 3 years experience in the pharmaceutical industry, in the fields of Quality Assurance or

production

Preferred: Supervisory Experience

 

SKILLS

• Understand scientific strategies and be able to invent new methods or new avenues of investigation
• Good interpersonal/communication/influencing/negation skills
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
• Lead Auditor training, ISO Lead Assessor training, with 2-3 years’ experience in auditing techniques, interpreting regulations and quality systems
• Computer knowledge of common office applications required