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Job Details

Quality Control Manager

Location
Parsippany, NJ, United States

Posted on
Jul 12,2019

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Qualified under GMP, FDA, 21 CFR, FSMA
Internal auditor trained and certified
Working knowledge of Preventative Controls (CAPA) as related to Dietary Supplements
Success Factors Self-motivated team player. Role model to subordinate employees. Well organized. Job Type: Full-time Experience: Quality Control: 5 years (Preferred)
Analytical Lab Testing: 3 years (Preferred)
Equipment And Process Validation: 2 years (Preferred)
Benefits offered: Health insurance
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Quality Control Manager
**MEMBERS ONLY**SIGN UP NOW***.
Parsippany, NJ
35 minutes ago
Full-time
Estimated: $76,000 - $99,000 a year
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Education
Bachelor's Degree
Skills
CGMP
Quality Control
Laboratory Experience
Industrial Laboratory Experience
High-Performance Liquid Chromatography
Benefits
Health Insurance
Title:
Quality Control Manager
Department:
Quality Control
Reports To:
Head of Quality & Operation
Manages QC laboratory which is responsible for raw materials and finished bulk product testing and release, and the development of standard test methods for chemical and physical characterization of products and materials. Provides these testing services and offers meaningful interpretation of results to both internal clients and external customers.
Troubleshoots analytical test methods and equipment malfunctions as required. Conducts laboratory investigations as related to the reporting of out of specification laboratory results.
Reviews and approves COA’s related to the release of finished bulk products. Analyzes raw materials and finished bulk product utilizing UPLC and other available laboratory techniques. Evaluates and recommends new testing equipment to support laboratory needs and requirements. Ensures that the laboratory operates in accordance with OSHA safety requirements. Serves as the contact person and hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations.
Trains the laboratory chemist/technician staff in laboratory techniques as required.
Prepares SOP’s, test methods, and laboratory reports as necessary.
Demonstrates familiarity with GMP’s and DSHEA as related to the laboratory function & Manufacturing processes. Interfaces with Manufacturing and Product Development as required to review results of product testing and to troubleshoot production problems.
Performs microbiological testing of incoming raw materials, in-process samples, stability, finished goods, and environmental monitoring samples for the QC Laboratory. Must be knowledgeable in basic laboratory reagent preparation, labeling, and handling.
Must demonstrate Good Laboratory Practice in completing daily work assignments.
Competent in performing basic mathematical and scientific calculations as they relate to job function. Knowledge of basic aseptic sampling and preparation techniques.
Ensures all procedures are being adhered to during the receiving, sampling, weighing, blending or compressing stages of manufacturing operations.
Knowledge, Skills, and Abilities Required
Experience developing UPLC, HPLC test procedures, and managing analytical services and staff.
Supervisory Responsibility
Directly supervises Micro & QC Lab technician & chemist, Raw Material sampler, other junior personnel as required.
Minimum Qualifications
B.S. degree in Chemistry.
Five to Eight years industrial laboratory experience.
Experience in QC laboratory environment.
Expertise in Nutraceuticals and/or Food/Pharmaceutical Science a plus.
HACCP / FDA HARPC Trained and Certified
FSC22000 Trained and Certified
Qualified under GMP, FDA, 21 CFR, FSMA
Internal auditor trained and certified
Working knowledge of Preventative Controls (CAPA) as related to Dietary Supplements
Success Factors
Self-motivated team player.
Role model to subordinate employees.
Well organized.
Job Type: Full-time
Experience:
Quality Control: 5 years (Preferred)
Analytical Lab Testing: 3 years (Preferred)
Equipment And Process Validation: 2 years (Preferred)
Benefits offered:
Health insurance
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