Sr. Quality Assurance Specialist at Polysciences, Inc. in Warrington, Pennsylvania

Job Description:

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

RESPONSIBILITIES:

Oversee daily operational activities and ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.

• Responsible for implementing and maintaining the effectiveness of the quality system.


• Manage the direct daily quality activities of a business unit as it relates to the QMS.


• Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures as it applies to a specific business unit.


• Drive process improvements by partnering with cross functional stakeholders.


• Review, revise, and approve SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.


• Participate in the preparation and review of QA files for site visits and regulatory inspections; assure that QA audit files are retained.


• Participate in client site visits and regulatory inspections.


• Management of a Change Control system that can lead teams to customer-oriented and compliant solutions.


• Working knowledge and application of root cause tools as they relate to Nonconformance, CAPA, and OOS systems.


• Perform internal audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.


• Assure the suitability of materials and supplies for compliance with specifications.


• Review, approve and/or reject or rejecting incoming materials, in-process materials and finished product.


• Perform all other related duties as assigned.

• Education: Bachelor’s degree preferably in a science or related discipline.


• Experience: Minimum 5 years experience in a Quality Assurance role or a GMP environment


• Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).


• Lead Auditor training to ISO 13485 preferred


• Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.


• Excellent judgment, decision-making, training/mentoring skills and verbal/written communication skills.


• Strong leadership, organizational skills and detail oriented.


• Able to prioritize workload and manage multiple tasks.

What We Offer

Culture

Great people

Peer to Peer Recognition

Broader, hands-on work experience

Clean and Modern Equipment & Labs

Fun company events

Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

4 Medical 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

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

Short & Long-term Disability

9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

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

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.  All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons.  Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.

Find us here Poly 400

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