Quality Assurance Controller - Polysciences, Inc.

The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discovery and innovations.

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 SOCMAs ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

Our specialty products business unit designs, replicates or refines formulations, optimizes analytical methods and develops scalable production processes of fine chemicals with a range of applications, such as biocompatible polymers and polymer precursors for medical devices, bioresorbable polymers for drug elution systems, high-end specialty industrials, energetic additives, and hard-to-find chemicals.

Our Contract Manufacturing business unit provides solid, liquid, and high viscosity custom blending and bottle, drum, tube, and pouch filling to our customers. Capabilities include hot-pour, emulsion and gel materials, flammable & hazardous, WFI grade and DI water, ISO 5 or 8 cleanrooms, and in-line labeling.

The Quality Assurance Controller reviews batch records and documents for product release.

Supports the control and accuracy of documents that will ensure that company products of the highest quality are developed, produced, controlled, and distributed according to the requirements of corporate policies, regulations of the U.S. Food and Drug Administration and ISO 13485, the Medical Device Directive, and other applicable regulatory requirements

• Review Batch Records to verify calculations, product accountability, accuracy, and proper GMP documentation practices and prepare them for product release.
• Analyze and review manufacturing and test data in written or electronic form to verify accuracy and completeness necessary for the final release. This also includes subcontractor records when product is processed by a 3rd party (i.e. sterilizer records).
• Performing Final Review and release of finished product.
• Review and Completion of Supplier Approval Documents, Activation and support of audits.
• Processing of Nonconformance and CAPAs associated with their division

This position ensures that all Nonconformances, deviations OOS and any special studies are adequately and appropriately documented and reported in the batch records.

• Works 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).
• Perform other related duties as required.

Qualifications:

• 2-3 years' experience in Quality Assurance
• QA experience in the medical device industry, preferable
• Knowledge of NC, CAPA, Design Control and Change Control
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP
• 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

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.

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