GMP TECHNICAL SPECIALIST
Company: Sever Pharma Solutions
Location: Putnam
Posted on: March 20, 2023
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Job Description:
Job Description:
Job Description Summary The GMP Technical Specialist is responsible
for the day-to-day setup, operation, disassembly and cleaning of
pharmaceutical equipment in both R&D and GMP manufacturing
environments. All work is to be completed in a compliant fashion in
accordance to current Good Manufacturing Practices (cGMP)
standards, FDA regulations (particularly 21 CFR Parts 210 & 211),
and Foster Delivery Science procedures and requirements. Essential
Duties & Responsibilities - Ensures all work is performed in
compliance to cGMP, FDA and company requirements; documentation is
complete and accurate. - Assists in the cleanliness of production
areas and equipment while ensuring procedures are followed and the
area meets all requirements for audit readiness. - Must wear and
abide by all safety precautions and wear the necessary personal
protective equipment for a given process. - Must understand and
follow instructions detailed in Development Records, Batch
Production Records and Packaging Records. - Must be able to work in
a fast-paced, priority changing environment. - Must possess
mechanical aptitude and equipment knowledge to be able to assist in
troubleshooting equipment issues. - Knowledge of disassembly,
assembly, cleaning and operation of pharmaceutical equipment within
a clean room setting, particularly extrusion equipment. - Manage
raw material, equipment and product inventory and warehousing, as
necessary. - Flexibility to work overtime, potentially on short
notice. Basic Qualifications - High School Diploma with at least 5
years' experience in medical device and/or pharmaceutical
manufacturing; equipment handling and the operation of in an
FDA-compliant environment - Higher education may be used in lieu of
experience - Working knowledge of Microsoft Word, Excel, PowerPoint
- Demonstrate attention to detail, problem solving and the ability
of multi-tasking and prioritizing - Great written and verbal
communication - Working knowledge of pharmaceutical GMPs and FDA
regulations - Must be able to work in a pharmaceutical clean room
environment - Able to use a variety of hand and power tools - Must
pass a baseline medical and pulmonary test Preferred Qualifications
- Able to work in a dynamic, fast-paced environment - Good trouble
shooting and problem-solving skills - Working knowledge of
extrusion with polymers and/or pharmaceutical materials Work
Environment - Must be able to lift up to 50 lbs - Will require
working in clean room, pharmaceutical manufacturing environment
including the use of gowning and other PPE including but not
limited to the use of PAPRs - May be exposed to high noise
environments - As noted, a baseline medical and pulmonary exam will
be required Monday through Thursday 6 am to 3:30 pm, Friday 6 am to
10 am PI207846893
Keywords: Sever Pharma Solutions, New England , GMP TECHNICAL SPECIALIST, IT / Software / Systems , Putnam, Northeast
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