Supervisor, Quality Assurance. 1st Shift

Under routine supervision, the Quality Assurance Supervisor is Responsible for tracking the release of finished products working with the various departments to ensure timely release of products. Supervises a staff of QA Batch Record Reviewers to ensure that batch records are reviewed for accuracy and consistency and are in compliance with SOPs and cGMPs Oversee the review of autoclave charts, drying loads, equipment preparation modules, equipment wash loads, component wash loads, depyrogenation tunnel charts and product sterilization records.

.
• 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
.
• BS/BA in Pharmaceutical related science field with 2 to 3 years' Pharmacecutical Quality experience or Associates Degree in Science or related field with 10 years' applicable experience.
.
• Supervisory Experience preferred.
.
• Computer knowledge of common office applications required. proficiency in Microsoft Access and Excel, desired.
.
• 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.
.

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.
.

Location:

Cherry Hill, NJ, US, 08003

Nearest Major Market: Philadelphia