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Biocoat · 2 months ago

Quality Control Associate

Horsham, PA

Full-time

Onsite

New Grad, Entry Level

$57K/yr - $62K/yr

Biocoat is committed to providing the best in developing, manufacturing, and applying coatings on medical devices. They are looking for a Quality Control Associate to establish and optimize laboratory procedures, perform quality control inspections, and support audit activities.

Medical Device

Responsibilities

Establish, execute, review, evaluate, and optimize laboratory procedures and policies

Perform, record and report quality control inspections and testing

Troubleshoot and participate in resolution of administrative or technical problems

Review batch records and supporting documents for production activities and release of product

Initiate, facilitate, assist, and review investigations and associated work for NCPs, CAPAs, ECOs, and failures for laboratory-related events

Assist with purchase, use, storage, and management of laboratory inventory/supplies

Investigate customer complaints

Coordinate Material Review Board (MRB) meetings and facilitate material and documentation dispositions, as needed

Author and review quality procedures, templates, forms, and reports

Communicate deficiencies, safety and/or compliance issues

Compile data and report QMS metrics as required (e.g., special projects, product study, Management Review)

Support audit preparation and performance audit activities

Qualification

ISO 9001ISO 13485QMS documentationBachelor’s degree in Life ScienceMicrosoft WordMicrosoft ExcelEQMSERP systemsAnalytical problem solvingMath skillsTechnical writingCommunication skills

Required

Bachelor's degree in chemistry, biology, biomedical engineering, or similar Life Science field required

Experience in regulated manufacturing lab setting a plus

Prior experience with ISO 9001 or ISO 13485, and/or experience with QMS documentation and Good Document Practices highly desirable

Ability to report, evaluate and interpret scientific data to be successful in this role

Excellent math skills to adequately perform and interpret calculations and test parameters needed

Analytical approach to problem solving; critical thinker; uses data to substantiate decision making

Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation with extreme detail required

Proficiency with Microsoft Word, Excel, and Outlook; Prior experience with eQMS or ERP systems highly desired

Ability to complete assigned tasks in a timely manner with minimal day-to-day direction while meeting deadlines

Strong interpersonal and communication skills (verbal/written)

Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required