Quality Control Chemist I

Cencora•Columbus, OH

2d•Onsite

About The Position

This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US. Under the general direction of the Senior Manager of Regulatory Affairs & Stability, the QC/Stability Chemist will focus on stability and release testing, as required, of products repackaged at AHP and work closely with other departments within the Quality Unit to ensure drug product meets all standards. Ensure stability and release testing activities are compliant with FDA, DEA, other regulatory body requirements as applicable. Ensure compliance with local and corporate policies and procedures. Perform stability and release testing for drug products in accordance with compendial and global requirements, as applicable. Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations. Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable. Perform review and release of stability and release tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately. Prepare lab reports as required. Assist with root cause investigations for quality incidents related to chemical analysis for stability and release tests. Maintain Quality System records and ensure completeness and accuracy. Coordinate with department management to identify and implement compliant process improvements. Clarify regulations, policies, and procedures to internal teams as applicable. Coordinates with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections. Conduct follow-up checks on the effectiveness of corrective actions Performs other duties to support Quality Systems and Regulatory Affairs department as assigned.

Requirements

Bachelor’s degree in chemistry or related field required.
Three or more years’ experience within a pharmaceutical manufacturing (cGMP) laboratory environment.
Working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.
Good oral, written, communication, and interpersonal skills.
Ability to develop and maintain cooperative working relationships with others.
Effectively interfaces with multiple levels of associates within the organization, including management and plant associates.
Ability to work independently.
Ability to handle a variety of tasks simultaneously.
Attention to detail.

Nice To Haves

Experience with MasterControl or other electronic quality management system preferred.
Familiarity with concepts of electronic documentation management systems (EDMS).

Responsibilities

Perform stability and release testing for drug products in accordance with compendial and global requirements, as applicable.
Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
Perform review and release of stability and release tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately.
Prepare lab reports as required.
Assist with root cause investigations for quality incidents related to chemical analysis for stability and release tests.
Maintain Quality System records and ensure completeness and accuracy.
Coordinate with department management to identify and implement compliant process improvements.
Clarify regulations, policies, and procedures to internal teams as applicable.
Coordinates with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
Conduct follow-up checks on the effectiveness of corrective actions
Performs other duties to support Quality Systems and Regulatory Affairs department as assigned.