QC Analyst II - Chemistry

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy. This role is involved with performing and assisting with OOS investigation and resolution. Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors.

Responsibilities

QC Testing/Safety

• Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.

• Adheres to Company safety procedures and guidelines on a daily basis

Documentation

• Adheres to Company safety procedures and guidelines on a daily basis.

GMP Compliance

• Adheres to Company safety procedures and guidelines on a daily basis.

Technical Writing & Investigations

• Assists with preparing new SOPs / test methods or revising of existing documentation.

• Performs and assists with OOS investigations, deviation response, and resolution.

• Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation.

Technical Transfer

• Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation

Other Tasks

• Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation.

Education & Experience

• B.S. in a Biological Science or related field with a minimum of 3-5 years' experience in pharmaceutical or biotechnology industry required OR

• M.S. in a Biological Science or related field with a minimum of 1-3 years' experience in pharmaceutical or biotechnology industry.

Knowledge

• Working knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).

• Working knowledge of cGMP practices, ICH requirements, stability, and validation required.

• Understanding of basic statistical analysis and familiarity with the use of databases is desirable.

Skills & Abilities

• Strong verbal and communication skills required.

• Proficient in common software applications.

• Ability to handle multiple priorities in a fast paced environment.

• Demonstrates excellent interpersonal skills and flexibility.

• Advanced writing skills.

• Proficient in running a great number of methods.

• Apply acquired biopharmaceutical skills to projects and assignments.

Physical Requirements

• Lifting up to 40 lbs.

• Able to stand for extended periods of time.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.