Supervisor, Quality Assurance, 2nd Shift

Under routine supervision, the Quality Assurance Supervisor oversees a staff of QA analysts, inspectors and technicians to ensure that raw materials in process materials, finished products and packaging are in compliance with chemical, biological, microbiological and/or physical quality control programs and external regulations.

 

• 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.

 

QUALIFICATIONS

• Minimum:   Associates Degree in Science or related field with 10+ years applicable experience.
• Preferred:   Bachelor’s Degree in Science or related field with 2-3 years’ Pharmaceutical Quality experience

EXPERIENCE

• Minimum:     10 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.

 

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.