Quality Control Chemist

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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.

Responsibilities include:

• Ensuring stability and release testing activities are compliant with FDA, DEA, other regulatory body requirements as applicable. Ensuring compliance with local and corporate policies and procedures.
• Performing stability and release testing for drug products in accordance with compendial and global requirements, as applicable.
• Developing, revising, and reviewing standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
• Assisting in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
• Performing review and release of stability and release tests for compliance to SOPs and regulatory requirements and ensuring data is reported accurately.
• Preparing lab reports as required.
• Assisting with root cause investigations for quality incidents related to chemical analysis for stability and release tests.
• Maintaining Quality System records and ensuring completeness and accuracy.
• Coordinating with department management to identify and implement compliant process improvements.
• Clarifying regulations, policies, and procedures to internal teams as applicable.
• Coordinating with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
• Conducting follow-up checks on the effectiveness of corrective actions.
• Performing other duties to support Quality Systems and Regulatory Affairs department as assigned.

Bachelor's degree in chemistry or related field required. Three or more years' experience within a pharmaceutical manufacturing (cGMP) laboratory environment. Should have a working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.

Experience with Master Control or other electronic quality management system preferred.

• 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.
• Familiarity with concepts of electronic documentation management systems (EDMS).

The work environment characteristics described here are representative of those an associate may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

• General pharmaceutical laboratory, production, and warehouse facility. The noise level in the facility is moderate.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

• Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
• Ability to lift up to 50 lbs.
• Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
• Associate is required to stand, walk (or otherwise be mobile).
• Ability to deal with stressful situations as they arise.