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Title: Specialist, Commercial Stability

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

• Duration: Temp
• Pay rate: $30-40/hr
• Job Location:  Boston, MA ( Hybrid)
• Job#: bh15622

Specialist, Commercial Stability

POSITION SUMMARY:

This role provides support for the coordination and execution of the commercial stability program within the Technical Operations Analytical department. This role is responsible for the timely processing of stablility data in a compliant manner, fostering good relationships with internal and external stakeholders, and living our vision and values.

KEY RESPONSIBILITIES:

• Support maintaining compliance of the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance intermediates, drug substance, drug product intermediates, and drug products.
• Transfer stability data from external contract testing laboratories to interval systems.
• Support entry of stability data into Laboratory Information Management Systems (LIMS) as well as verification of stability data entries.
• Effectively communicate with internal and external stakeholders

EDUCATION AND EXPERIENCE:

• A minimum of a bachelor’s degree in science or related discipline is required.
• 2 years of experience in the pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
• Basic knowledge and understanding of analytical methodologies such as chromatography, dissolution, water content, and physical data
• Experience with electronic document management systems
• Experience with Laboratory Information Management Systems (LIMS)
• Experience with statistical software and its application to support data entry
• Knowledge of US and EU cGMP regulations/guidance.
• Ability to prioritize objectives from multiple projects, and adhere to scheduled timelines while maintaining flexibility and attention to detail
• Effective communication skills, both verbal and written.

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