Description

The Associate Scientist, Bio QC performs bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virological) for various Bio QC tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. This role initiates, executes and completes assays as per validated procedures and within Quality and Compliance guidelines and communicates testing results, compliance and/or scheduling issues to supervisors.

The Scientist I, Bio QC performs bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virological) for various Bio QC tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. This role initiates, executes, completes, and communicates results and related issues as per validated procedures and within Quality and Compliance guidelines.

Duties & Responsibilities

• Performs routine testing using a portion of the existing laboratory assays.

• Maintains laboratory reagents, supplies and calibrated equipment.

• Prepares reagents and materials.

• Calculates test results.

• Communicates schedule, test status and concerns.

• Reviews and approves results and test sheets.

• Revises a Pre-existing Standard Methods and SOPs.

• Trains others on methods & procedures.

Requirements - Associate Scientist, Bio QC

• High school degree or GED with a minimum of five (5) years of relevant Bio QC testing or relevant experience in a cGMP or similar environment.

OR

• Associate's degree in relevant scientific discipline and a minimum of two (2) years of Bio QC testing or relevant experience in a cGMP or similar environment.

OR

• Bachelor's degree in relevant scientific discipline with or without additional Bio QC testing experience.

• Bachelor's degree in a scientific discipline with one-plus (1+) years of Bio QC testing experience in a cGMP or similar manufacturing environment is preferred.

• Knowledge of basic scientific principles and techniques.

• Ability to effectively communicate in a clear, concise and appropriate manner.

• Documents results and data clearly and accurately.

• Effectively interacts with co-workers and others as needed.

• Demonstrates teamwork within own group and other internal groups.

• Use of Word and Excel, QM software for data management (SAP), MRP inventory software, and Document Management System)

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.

• Must be willing to take a drug test and post-offer physical (if required).

• Must be 18 years of age or older.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.