Quality Assurance Specialist
Company: Coda Staffing
Posted on: February 22, 2021
ResponsibilitiesPerforms QA oversight of Production activities
including Compounding, Filling, Inspection, Labeling and Packing.
Oversight and confirmation of cleaning of rooms, parts, equipment
and surfaces to assure compliance with cleaning requirements
- Oversight and confirmation of compliance in Compounding
processes including room clearance, verification of material
status, weighing, mixing, charging of chemicals, in-process quality
attributes, autoclave, compliance with batch record instructions
and sequence, documentation verification, logbook documentation
- Oversight and confirmation in compliance of Filling Operations
including line clearance, material status, aseptic technique,
in-process quality attribute testing, documentation on forms and
- Verification of proper gowning by all personnel in all areas of
- Verification of environmental monitoring activities including
plating, Lighthouse and personnel monitoring.
- Generation of deviations, issuance of CAPAs, Change Controls in
response to observations
- Follow up with Quality Assurance Management on quality issue
tracking and trending activities also include batch record review,
batch release, visual inspection and any other activity assigned by
Quality Assurance management.
- Oversee all Quality aspects on the floor
- Product label review and approval
- Participate in regulatory audits
- Performs or assists process owners with root cause
- Prepares and monitors Quality Metrics and KPI's
- Performs duties in accordance with established company
procedures and policies; performs other duties as
- 3 plus years' experience with aseptic drug product
manufacturing is required.
- A fundamental, working knowledge of safety, quality systems,
and quality assurance concepts is required including the
application of current Good Manufacturing Practices and Good
- Strong familiarity with manufacturing process and operations,
automation, equipment/facilities validation
- Familiarity with FDA inspections and audits
- Investigation writing skills.
- Ability to complete tasks with little direction or need for
- Strong written, verbal and presentation communication
- Strong computer skills in database management and documentation
preparation (Word, PowerPoint, Excel, and other must be able to
learn additional software as required).
- Ability to think creatively in confronting new issues and
pursuing novel approaches to old problems.
- Ability to work under pressure, meet deadlines and exercise
sound business judgment with critical thinking skills and high
- Work schedule flexibility.Experience:
- 3-5 years of progressive experience within cGMP quality
operations and FDA regulations or a 503B outsourcing facility,
aseptic/parenteral manufacturing/development environment or
equivalent technical experience.
- High school degree
- BS in Scientific field preferred
Keywords: Coda Staffing, Paterson , Quality Assurance Specialist, Other , Boonton, New Jersey
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