Quality Assurance Associate (Manufacturing)

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 GMP 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 Associate reviews batch records, receiving documentation, Quality Control Raw Data and other associated documents for product/material 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:

• 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

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

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

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

The QA Associate plays a key role in supporting the release of high-quality products and materials. This role is responsible for reviewing batch records, receiving documentation, and quality control (QC) raw data to ensure compliance with corporate policies, FDA regulations, ISO 13485 standards, and other applicable regulatory requirements. The QA Associate supports the accuracy and control of documentation necessary for product release and collaborates across departments to meet production and customer demands.

Essential Functions: Fundamental and critical tasks, duties, and responsibilities necessary for position to be performed effectively.

• Verify calculations, product accountability, accuracy, and proper GMP documentation practices in batch records. Prepare records for product/material release.
• Analyze and review manufacturing and test data (written or electronic) to confirm accuracy and completeness for final product release. This includes reviewing subcontractor records when product is processed by third parties (e.g., sterilizer records).
• Perform final review and release of finished products, ensuring all documentation is accurate and complete.
• Ensure all non-conformances, deviations, out-of-specifications (OOS), and special studies are documented and reported within batch records.
• Prioritize deliverables based on multiple inputs from departments and competing customer demands.
• Track batch record errors, monitor review turnaround times, and maintain a batch accuracy log.
• Participate in the internal audit program of departments and processes and support external audits as needed.
• Support company goals, objectives, policies, procedures, and Quality System Regulations (QSR) compliance.

Qualifications

Education Required: High School Diploma/GED                                                  Preferred: Bachelor's Degree                     

Certification(s): Specify preferred or required.

Good Documentation Practices (GDP) Certification preferred

Computer Skills Required: Specify preferred or required.

Proficiency with Microsoft Office Suite.

Preferred experience with Enterprise Resource Planning (ERP) systems.

Preferred experience with internal and external audit processes.

Other qualifications:

• Working knowledge of ISO 13485, FDA GMP, and other relevant regulatory standards.
• Experience with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Familiarity with non-conformances (NC), Corrective and Preventive Actions (CAPA), and Change Control processes.
• Strong attention to detail, organizational skills, and time management abilities.

Immediate Work Environment:

Chemicals                     Unprotected Height           Fumes/Gases          Persistent Noise

PPE used: Click or tap here to enter text.

Work Activity: [must equal number of hours worked per day]              

Stand:     1             Frequency:  Intermittently                           Walk:     1             Frequency:  Intermittently          

Sit:          6             Frequency:  Continuously                             Drive:      0             Frequency:  Choose an item.          

Life/Carry Demands

Frequency:                                                            Lift/Carry Equipment Provided:

0-10 lbs.                 Less than 1 hour a day                        Click or tap here to enter text.

11-25 lbs.              Rarely                     Click or tap here to enter text.

26-50 lbs.              Never                     Click or tap here to enter text.

51-75 lbs.              Never                     Click or tap here to enter text.

76-100 lbs.            Never                     Click or tap here to enter text.

Salary Minimum: 55000Salary Maximum: 65000