Quality Assurance Team Leader -3rd Shift

Job Title: Team Leader Quality Assurance
Reports To: Quality Assurance Manager
Group/Division: BioPharma Services Division
Business Unit: Fisher Clinical Services
Career Band: III
Job Track: Management
Position Location: Allentown, PA
Number of Direct Reports: Approximately 5
Day/Shift (if applicable): First, Second, or Third Shift
FLSA Status (Exempt/Non-Exempt): Exempt
Position Summary: This position is responsible for the direct supervision of Quality Assurance Inspectors in packaging / manufacturing operations in order to assure compliance with CGMP's and company SOP's.
Key Responsibilities:
Applies Good Manufacturing Principles in all areas of responsibility.
Demonstrates and promotes the company vision.
Schedules QA staff in overseeing packaging / manufacturing operations.
Works with room leaders and production team leaders to assure quality-oriented operations.
Instructs QA staff in proper inspection procedures and techniques.
Periodically reviews all aspects of packaging operations as related to quality - staging, reconciliation, in-process inspection, label control, etc.
Assures that batch paperwork is completed accurately and in a timely manner.
Reviews packaging concerns with production management and resolves conflicts.
Assists QA Inspectors in staging and closeout operations when required.
Assist on training development for CGMP's, SOP's, safety, quality, etc as required
Provides positive and critical feedback to employees relating to their job performance.
Completes the regular performance evaluation of QA Inspectors including the identification of development needs.
Minimum Requirements/Qualifications:
To perform this job successfully the individual must be experienced with QA procedures in a highly regulated industry where GMPs are required, preferably in the pharmaceutical environment. For internal applicants, must have extensive familiarity with packaging paperwork and a sound understanding of CGMP's and SOP's.
Education/ Experience (BMQ):
High School diploma with college degree, 4 year degree preferred with a major in biology or chemistry and two years of related pharmaceutical or FDA regulated industry experience preferred, or equivalent combination of education and experience. Experience in a fast-paced environment.
Internal/External Contacts: This position has internal contact with Production Technicians, Production Management, QA Management, Engineering, Client Services, and Logistics. External contact - Customer representatives monitoring packaging operations.
Supervisory Responsibility:
This position is responsible for the direct supervision of QA Inspectors on the shift.
Ability and/or Skills (BMQ):
Requires excellent supervisory skills and leadership ability. Must be comfortable with decision-making on quality issues. Requires ability to multi-task and prioritize.
Physical Demands: Extensive standing and walking on packaging floor in order to monitor room activities and instruct QA Coordinators.
Work Schedule:
Monday through Friday, 8 hours per day. Additional overtime and weekend work may be required.
Job Category Operations
Quality
Country / State ? City US - Pennsylvania - Allentown Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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