Quality Assurance Specialist

  • Horsham, PA
  • Full Time
  • Quality Control
  • Experienced

Eligible for a Sign-On Bonus! Salary Range $57,000-$65,000, Discretionary Annual Bonus

Benefits: Medical/Dental/Vision with Shared Company Cost, Company Paid Life Insurance and Disability, Flexible Spending Account, 401(k) w/ Company Match, Paid Time Off, Parental Leave, Education Assistance and More!

Biocoat is a global leader in developing, manufacturing, and applying hydrophilic coatings to medical devices. We are looking for a dedicated associate to be part of our team oriented and friendly work environment as a Quality Assurance Specialist. The QA Specialist will assist in the support, oversight, and management of daily Quality Assurance activities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Review and approve batch records and supporting documents for production activities and release of product, ensuring all associated discrepancies and deviations are documented and closed appropriately
  • Administration of QMS documentation including authoring, formatting, and reviewing quality procedures, templates, forms, and reports, and developing/revising/implementing additional procedural and work instructions as necessary
  • Serve as Document Control and Training SME and electronic QMS (e.g., Grand Avenue) administrator
  • Implement, review, and facilitate investigations: perform and lead root cause analysis groups, risk analysis, and effectiveness monitoring and close Corrective and Preventive Actions (CAPA)
  • Assist with and/or lead investigation and resolution of customer complaints
  • Assist in and/or lead the management of change controls/ECOs and associated activities
  • Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
  • Communicate deficiencies and/or compliance issues to QA/RA management
  • Responsible for driving individual and department goals and initiatives for continuous improvement of procedures, processes, and systems
  • Participate and lead low to medium level, cross-departmental projects
  • Compile data and report QMS metrics as required (e.g., Leadership Team meetings, KPIs, Management Reviews, Quality Reviews)
  • Administer and deliver Quality Assurance training, including new employee onboarding and Training system management
  • Create and deliver training materials for quality-related functions and topics as needed
  • Coordinate and perform audits (internal, process) as required
  • Support and organize audit preparation and performance activities
  • Support testing and release activities for Quality Control (QC) as needed and appropriate

QUALIFICATIONS & REQUIREMENTS:

  • Bachelor’s degree in a Scientific or Life Science field or equivalent work experience
  • 1-3 years of experience in a Quality function, experience with QMS documentation and Good Document Practices and/or internal/lead auditor experience highly desirable
  • Experience with ISO 13485 highly preferred
  • External certification, (CQA, CQE, RAC, etc.) is preferred
  • Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation
  • Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
  • Prior experience with eQMS systems highly desired
  • Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
  • Ability to work proficiently and independently in a regulated manufacturing setting
  • Independent, self-starter; able to complete assigned tasks in a timely manner with minimal day-to-day direction; keen attention to detail and ability to follow directions
  • Represent the company in a positive and professional manner during supplier, customer, and regulatory visits
  • Ensure interactions are consistent with company values and treats others with dignity and respect
  • Ability to effectively present and lead in formal, one-on-one, and group situations
  • Strong interpersonal skills and ability to work with others in a positive and collaborative manner
  • Organized with ability to identify and manage priorities; ownership of an issue or project to resolution; reliable follow-up and follow-through as needed
  • Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required.

Biocoat is an is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other protected characteristic under law.

Biocoat Human Resources leads recruitment and employment for Biocoat. Unsolicited resumes sent to Biocoat from recruiters do not constitute any type of relationship between the recruiter and Biocoat and do not obligate Biocoat to pay fees should we hire from those resumes. We ask those external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

 

 

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