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Quality Control (QC) Analyst

Company: Pine Pharmaceuticals
Location: Tonawanda
Posted on: September 21, 2022

Job Description:

_About Us_ _Pine is a family-owned and operated pharmaceutical company located in Tonawanda, NY along the beautiful Niagara River in the scenic Riverwalk business park. Our team is growing dramatically to meet the tremendous demand for sterile compounded drugs used by physicians every day across the country. Driven by teamwork, Pine is a prominent leader in the 503B outsourcing space, where we continue to innovate._ _What it's like to work here_ _Pine was founded on a culture of caring, and not just about the specialty coffees available on-campus! At Pine, our employees care about each other, about our community, and about the patient who will ultimately receive the drugs we are responsible for compounding every day.__There are a lot of perks working for Pine, including regularly catered lunches, employee appreciation programs, generous discretionary bi-annual profit sharing, healthy work-life balance, and much more! Above all else, Pine Pharmaceuticals is a family-owned and operated company, and employees are treated just like that. Family!_

Job Description:

S ummary: This laboratory position is located within the Quality Control (QC) Department and involve performance of applicable testing to support cGMP manufacturing. Responsibilities: The QC Analyst is responsible for daily laboratory operations and conducting routine and non-routine analyses within production and cleanroom environments in a cGMP compliant facility. J ob Scope: Execution of QC analyses to support manufacturing of compounded pharmaceuticals including but not limited to environmental monitoring, sterility assurance testing, endotoxin, and particulate analysis, per governing USP chapters and FDA regulations. Promotes a cGMP/cGLP environment within the laboratory by adhering to safe work environmentbehavior and work integrity. Maintenance of testing equipment including analytical and microbial instrumentation Evaluation of environmental monitoring results (i.e., off-testing), including:Media fill study resultsFinished product testing results, andDocumentation of such results. Routine performance of testing within certified cleanroom environments. Maintenance of close communication and interaction with QC/QA management. Utilization of both Enterprise Resource Planning (ERP) for daily workflow. Utilization of a Quality Management System (QMS) for trainings and document review/improvements. Potential involvement in procedural/policy improvements within the department. May assist and perform OOS/OOT or nonconformance investigations for out of limit results. Responsible for assisting in the cleanliness and upkeep of the laboratory. Qualifications: BA or BS in science related field (preferred) One year (or more) working experience in pharmaceuticals. Excellent time management skills Attention to detail Good documentation skills/practices Ability to adhere to implemented standard operating procedures/policies Ability to communicate professionally with contract laboratories regarding sample testing. Effective at communicating with others Working well independently while maintaining a team-oriented mindset Remaining flexible for new opportunities/tasks. cGMP and cGLP experience not required, but desired. Additional Skills: Comfortable working in a cleanroom environment Familiarity with maintenance and use of laboratory equipment Strong computer skills Working knowledge of general MS Office applicationsJob Type: Full-time

Keywords: Pine Pharmaceuticals, Tonawanda , Quality Control (QC) Analyst, Professions , Tonawanda, New York

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