QA Supervisor - 2nd Shift


Job ID 18-00016

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

SUMMARY
Performs quality assurance duties to prevent or eliminate defects in products for sterile filling operation or in final inspection operation. The QA Supervisor of Quality Operations schedules and reviews in-process auditing of all facility operations. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with Company policies and procedures as well as cGMP's.

ESSENTIAL FUNCTIONS
•Oversees day to day operational QA activities for sterile products manufactured at the facility.
•Supervise, train, mentor, and succession planning for QA Technicians.
•Dispositions raw materials and packaging components.
•Develop, draft, update, modify procedures related to operational Quality activities.
•Review, comments, approve functional area procedures.
•Review or oversight of compliance documentation such as data for work orders, incubators, refrigerators, freezers, and temperature/humidity in classified areas.
•Documents and investigates deviations, and non-conformances.
•Monitors the production processes and ensure consistency of procedures.
•Involvement in decision making to stop production if quality standards are not being met.
•Oversees the inspection and AQL sampling of finished products.

ADDITIONAL RESPONSIBILITIES
•Works with CAPA Coordinator or designee to ensure items are completed, documented and timely.
•Assists with CAPA effectiveness checks

SUPERVISORY RESPONSIBILITIES
•Directly responsible for performance reviews, goal setting and personnel development plans for QA Technician I and II
•Recruiting, interviewing and hiring qualified employees to fill open positions.
•Addressing complaints and resolving personnel problems within the department
•Maintaining confidentiality of information.



Qualifications

JOB PREREQUISITES
•All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
•Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's.
•Have general math skills; adding, subtracting, multiplication, division and percentage calculation. Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.
•Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications.
• Strong verbal and written communication skills. Resourceful and well organized.
•Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.
•Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CANDIDATE DETAILS
5+ to 7 years' experience
Seniority Level - Mid-Senior
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel – Never

EDUCATION AND EXPERIENCE
•Bachelor's Degree (BS or BA)
•5-10 years demonstrated excellence in in the pharmaceutical or related industry

SAFETY REQUIREMENTS
Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility