Quality Control Scientist

Job Description

Job Description

We are seeking a highly skilled and motivated Senior Quality Control Associate to join our dynamic team at a leading Midwestern biopharmaceutical company.

This role is ideal for a professional with a strong background in Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) and extensive experience in the development, optimization, qualification, and validation of analytical assays.

In this position, you will have the opportunity to work with a broad and diverse portfolio, employing a wide range of techniques in a company that is pioneering a unique platform with significant scientific impact.

As we move toward commercialization, you will play a crucial role in ensuring the highest standards of quality and innovation are maintained.

The Senior Quality Control Associate is expected to possess strong time management skills, handle multiple activities simultaneously, work with minimal supervision, be detail-oriented and accurate, and exhibit a passion for continuous improvement.

Essential Duties and Responsibilities :

Responsibilities include but are not limited to :

Lead the development and validation of complex bioanalytical assays, including but not limited to ELISA, receptor binding, cell-based, immunoassays, bioassays, and ligand binding assays.

Effectively communicate data at department and cross-functional teams and contribute to bioanalytical sections for IND reports and / or publications.

Evaluate and revise specifications based on stability studies.

Perform various scientific functions competently, including physical property characterization assays, HPLC, ELISA, PCR, gel electrophoresis, cell culture, and aseptic technique.

Work proficiently under GLP and / or cGMP conditions, maintaining compliant records of scientific work.

Assist in the development of analytical assays and laboratory systems, collaborating with technical support, CMO collaborators, and analytical consultants.

Draft and revise ROPs, SOPs, Data Records, Study Protocols, and Study Reports.

Provide general assistance in the function of the QC Laboratory.

Participate in scheduled general cleaning of laboratory facilities.

Assist in preventative maintenance and cleaning of equipment.

Contribute to the training of junior associates in various activities.

Mentor junior associates in assay development and laboratory techniques.

Collaborate with external partners and vendors in assay development projects.

Perform duties as directed by the supervisor.

Qualifications :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.

Education, Experience and Certifications :

Master’s degree and 3 years of experience OR

Bachelor’s degree and 5 years of experience

Demonstrated experience in an aseptic environment

Extensive experience working under GLP or GMP.

Company Description

At Insight Recruitment, we specialize in the placement of Enterprise Resource Planning (ERP), Information Technology (IT), Sales & Marketing, Behavioral & Mental health, and Executive professionals in all varieties of industries & disciplines.

Offering a boutique-style service, we have grown organically over the years through word-of-mouth referrals and have become the Agency of Choice for companies who need the right talent to join their firm.

Our Services Include Direct hire, Contract, or Contract-to-hire.

We have served a wide variety of firms in the Midwest and nationwide since 1998 and as a result we have come to truly know our client's culture, their business demands and subsequently their hiring needs.

Everything is evolving in today's marketplace and the most innovative professionals are driving this market. The success of your company relies on how you can attract, engage and hire these people : this is where we can help.

A Dynamic Approach

Over 85% of our business comes from referrals; that's a powerful testament to the quality of service we deliver. Companies want to be truly heard and understood when they are working with an agency to help them find and secure the best talent available.

Many come to us because they're tired of the larger nationwide chains only providing mediocre candidates, and they want better results.

And that is what every company receives with us : better results."

Kinga Wilson, Senior Search Consultant and Owner of Insight Recruitment

Company Description

At Insight Recruitment, we specialize in the placement of Enterprise Resource Planning (ERP), Information Technology (IT), Sales & Marketing, Behavioral & Mental health, and Executive professionals in all varieties of industries & disciplines.

r n r nOffering a boutique-style service, we have grown organically over the years through word-of-mouth referrals and have become the Agency of Choice for companies who need the right talent to join their firm.

r n r nOur Services Include Direct hire, Contract, or Contract-to-hire. r n r nWe have served a wide variety of firms in the Midwest and nationwide since 1998 and as a result we have come to truly know our client's culture, their business demands and subsequently their hiring needs.

Everything is evolving in today's marketplace and the most innovative professionals are driving this market. The success of your company relies on how you can attract, engage and hire these people : this is where we can help.

r n r nA Dynamic Approach r n r n"Over 85% of our business comes from referrals; that's a powerful testament to the quality of service we deliver.

Companies want to be truly heard and understood when they are working with an agency to help them find and secure the best talent available.

Many come to us because they're tired of the larger nationwide chains only providing mediocre candidates, and they want better results.

r n r nAnd that is what every company receives with us : better results." r n r n- Kinga Wilson, Senior Search Consultant and Owner of Insight Recruitment