QC - Stability Coordinator

Overview

The successful candidate will be responsible for development and management of the Kashiv Piscataway stability program. The responsibility includes collaboration on development and execution of stability protocols and SOPs related to the stability program. The candidate will be expected to work with IT and Purchasing to validate and implement a stability software program. The position is responsible for all aspects of the stability program, including placing samples on stability, entering information into the scheduling database, pulling samples, scheduling testing, and ensuring testing is completed. An ability to conduct investigations and deviations and develop CAPAs and Change Controls is required. Stability chamber maintenance and management is a part of this role. Ability to collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required. The performance of general QC testing (release and stability) is also expected. The candidate will also be expected to ensure continuous coverage of the stability management function by selecting and training two individuals to be data verifiers of data entry and back up whenever absent.

Responsibilities

• Manage stability program for Kashiv Piscataway
• Contribute to and approve stability protocols
• Maintain documentation for stability samples, including logbooks and test records
• Serve as QC point of contact for installation of stability software, including drafting of design and user requirements, oversee and support execution of software validation and implementation
• Responsible for placing samples on stability, pulling samples, ensuring completion of testing, recording tracking and trending of test results
• Handle alarms and excursions for stability chambers
• Initiating and completing deviations, CAPAs, OOS, laboratory investigations, and Change Controls related to the stability program
• Perform testing as needed
• Train backup for role to ensure no disruption in stability program when absent
• Support other QC operations as needed
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Qualifications

Experience:

• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.
• Experience with OOS and Laboratory Investigations, Deviations, Change Controls and CAPAs.

Special Skills:

• Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed.
• General understanding of medical terminology, clinical trials, and drug development process.
• Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• High degree of fluency in written and spoken English.
• Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
• Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).

EDUCATION

Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with experience in stability program management with a minimum of 6-8 years of experience in a pharmaceutical/biotech QC laboratory.  Alternatively, Master’s degree in above areas with 4 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.