Lead Quality Controller - 0QK3985545  

DESCRIPTION/RESPONSIBILITIES: 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.

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:  * 3-5 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  * 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 an /or interview process should notify a representative of the Human Resources Department.