Job Description:

Cambrex


QC Stability Coordinator

US-NC-High Point

Job ID: 2024-3702
Type: Regular Full-Time
# of Openings: 1
Category: Quality Control
Cambrex - High Point

Overview

The Stability Coordinator, reporting to the QC Manager, will be responsible for maintaining the stability program of Cambrex High Point (CHP) customer products. This role will ensure the stability program meets the expectations of all regulatory agencies and remains compliant with applicable Company SOPs and regulatory guidance’s. This position will be required to work well with cross functional teams and will be the key point of contact for the CHP stability program.

Responsibilities

• Maintaining a compliant stability program meeting client needs and expectations.
• Write stability protocols, protocol change forms, interpreting stability trend results and writing
• Perform stability staging and document in laboratory notebook.
• Maintain inventory of stability staging supplies and reorder as needed.
• Ship samples for outside testing and post results for review.
• Monitoring and maintaining chambers (may involve on-call).
• Work closely with QC, data review and QA colleagues to ensure timelines are met and reports are accurate.
• Interaction with clients for review of stability documents and addressing client questions.
• Oversee reference standard program.
• This position works with and handles hazardous materials and waste at Cambrex. Must have the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.

Qualifications

BS or MS in Chemistry (or closely related discipline). Strong comprehension and facility in quantitative/qualitative analytical Chemistry. A minimum of at least 4-6 years of strongly relevant background in GMP/QC-compliant analytical testing in a pharmaceutical laboratory environment.

PI240092511

Salary: $65,000.00

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