Quality Assurance Associate

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...