Quality Assurance Specialist

2 weeks ago

Warrington, Pennsylvania, United States Polysciences Full time
Quality Assurance Associate

Polysciences is seeking a Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will be responsible for reviewing batch records, receiving documentation, and quality control raw data to ensure that company products meet the highest quality standards.

Key Responsibilities:

  • Review batch records to verify calculations, product accountability, accuracy, and proper GMP documentation practices.
  • Analyze and review manufacturing and test data in written or electronic form to verify accuracy and completeness necessary for final release.
  • Perform final review and release of finished product.
  • Ensure all nonconformances, deviations, and special studies are adequately and appropriately documented and reported in batch records.
  • Work with all facets of the company, including receiving, planners, shipping, and technical representatives from manufacturing to best support production build and shipping schedules.
  • Prioritize deliverables to team based on multiple input departments and competing customer demands.
  • Track batch record errors, monitor them for review turnaround times, and maintain batch accuracy log.
  • Exhibit an excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
  • Participate in internal audit program of departments and processes at the site.
  • Participate in and support external audits as needed.
  • Support company goals and objectives, policies, and procedures, and Quality System Regulations (QSR).

Requirements:

  • 1-2 years' experience in Quality Assurance.
  • QA experience in the medical device industry, preferable.
  • Knowledge of NC, CAPA, and Change Control.
  • Working knowledge of ISO 13485, GMP.
  • SAP/Batchmaster knowledge, preferable.
  • Proficient in Microsoft office suite (Word, Excel, PowerPoint, Outlook).
  • Effective word processing skills.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to work effectively in a cross-functional environment.
  • Ability to integrate quality objectives across multiple functions.
  • Attention to detail, strong organizational skills, and time management are essential.
  • Demonstrates good organizational and communication skills.
  • Must be able to work independently with minimal supervision.

Benefits:

  • 3 PPO Medical Plans with Telemedicine, Rx, & Vision.
  • 2 Dental Plans.
  • Healthcare, Dependent care, & Commuter Flexible Spending Accounts.
  • 401(k) with company match.
  • Financial Health & Wellness w/1:1 Coaching & Rewards.
  • Basic & Supplemental Life Insurance.
  • Accident, Hospital Indemnity, & Critical Illness.
  • Paid Time Off.
  • Paid Parental Leave.
  • Short & Long-term Disability.
  • 9 Paid Holidays.

Equal Opportunity Employer:

Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Language:

English.

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