Stability Associate II

1 week ago

New Haven, United States Careers Integrated Resources Inc Full time

Job Title: Stability Associate II (Analytical Development and Quality Control) Location: New Haven, CT (100% onsite) Duration: 12 Months+ (Possibilities of Extension) Pay Rate - $37.93/hr. on w2 This is what you will do: The Stability Associate II is responsible for performing assigned tasks to support stability activities for Client’s clinical phase candidates from development through Phase III and support Commercial Products. The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required. You will be responsible for: • Responsible for all aspects of on-site stability sample storage and sample management • Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans • Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs) • Perform data entry/review within paper-based and electronic systems • Point-of-contact between on-site testing labs and stability group • Author stability Protocols, Reports, SOPs and Quality documents as required • Work with internal stakeholders to provide testing requirements and obtain completed analytical test results • Track stability results generated internally and at external CMOs/ CLOs • Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required • Perform all job functions in compliance with cGMPs and maintain accurate and legible records • Ensure training is current for all job functions performed. Attend all required Company training.

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    4 weeks ago

    New Haven, United States Careers Integrated Resources Inc Full time

    Job Title: Stability Associate II (Analytical Development and Quality Control) Location: New Haven, CT (100% onsite) Duration: 12 Months+ (Possibilities of Extension) Pay Rate - $37.93/hr. on w2 This is what you will do: The Stability Associate II is responsible for performing assigned tasks to support stability activities for Client’s clinical phase...

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    2 weeks ago

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    Job Title: Stability Associate II (Analytical Development and Quality Control) If the following job requirements and experience match your skills, please ensure you apply promptly. Location: New Haven, CT (100% onsite) Duration: 12 Months+ (Possibilities of Extension) Pay Rate - $37.93/hr. on w2 This is what you will do: The Stability Associate II is...

  • Stability Associate II

    2 weeks ago

    New Haven, CT, United States Careers Integrated Resources Inc Full time

    Stability Associate II (Analytical Development and Quality Control) The Stability Associate II is responsible for performing assigned tasks to support stability activities for Client’s clinical phase candidates from development through Phase III and support Commercial Products. The Stability Associate II will work in collaboration with members of...

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    1 day ago

    New Haven, CT, United States Careers Integrated Resources Inc Full time

    Job Title: Do not wait to apply after reading this description a high application volume is expected for this opportunity. Stability Associate II (Analytical Development and Quality Control) Location: New Haven, CT (100% onsite) Duration: 12 Months+ (Possibilities of Extension) Pay Rate -$37.93/hr. on w2 This is what you will do: The Stability Associate II...

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