Piney Technical Services
GENERAL PURPOSE OF JOB:
This position is responsible for providing technical support and leadership within the Quality organization, as well as coordinating Quality activities in line with FDA and other regulatory requirements.
Directly supervise the Quality Assurance Analysts to insure the proper level of support is provided throughout the plant.
Oversee the required training for new lab analysts.
Coordinate and assign daily work priorities within the laboratory
Ensure timely completion and reporting of all analyses to support product release
Ensure timely completion of all required plant safety training.
Performs required testing to support all production requirements including Raw Materials, Intermediate and Finished Products.
Maintain the LIMS database.
Oversees the Retention and Stability Sample program
Manage and order all chemicals and reagents.
Maintain proper calibration of scales and all lab instruments.
Maintain tracking of material Expiration/Retest dates
Assure compliance with Company and Government regulations.
Provides analytical support to Validation Protocols. Insures all required testing is completed and reviews data as necessary for summary reports. Insures all specifications and new methodology is in place to support the start of production.
Initiates LIRs and Non-Conformance reports for Raw Materials, Intermediate products and finished products.
Authors and approves SOPs and Work instructions to support quality systems.
Participate in root cause investigations on product failures and recommends corrective/preventative actions to resolve the failures.
Provides support to internal and external customers regarding quality related issues.
Basic Minimum Requirements:
Meet the legal minimum age requirement
Authorized to work in the United States
Bachelor of Science Degree in Chemistry or related field
3 years experience working in a cGMP regulated facility
3 years experience performing analytical testing involving wet chemistry related applications
2 years experience in preventive maintenance, calibration and troubleshooting of analytical lab instruments
2 years supervisory experience
Ability to work all shifts
Ability to work overtime as needed
Other Required Skills:
Ability to work independently and as part of a team
Strong attention to detail, planning and organizational skills
Strong written, verbal and interpersonal skills
2 years experience working with LIMS
2 years experience in Technical Writing (i.e. methodologies, SOPs, LIRs)
Able to sit for long periods of time utilizing a computer
Able to stand for long periods of time
Lifting up to 25 lbs
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Piney Technical Services