Job description

The Stability Chemist is responsible for executing tasks and testing to support the Stability Program. Stability Program job functions are to be executed in compliance with internal standard operating procedures and ICH guidelines. This position is responsible for packaging stability, sampling stability, and assisting with the testing related to stability.

Essential Duties and Responsibilities:

• Assist with the generation/review/approval of Stability documentation, which includes but is not limited to SOP’s, analytical testing packets, Stability Data Cards, Protocols and Reports
• Assist with stability analysis, review for testing, and transcription to stability data cards.
• Responsible to enter the stability analysis results into the appropriate spreadsheet to track and trend data for each stability study
• Assist with stability component inventory and inventory of stability samples
• Responsible for placing batches on stability, which includes packaging and placing in the appropriate location
• Ensure stability chamber organization, maintenance and support
• Assist in enforcing proper documentation for each stability analysis
• Collaborate interdepartmentally to help resolve a quality issue related to the stability program
• Other duties may be assigned as deemed appropriate by management

Qualifications:

• Bachelor’s degree or higher in Science Field, Chemistry Degree or other related field and/or commensurate experience required.
• Experience in pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations and guidance, is required.
• Ability to interpret data, perform complicated analytical calculations and statistical analysis
• Must be able to communicate technical, scientific, and regulatory information, both written and verbally
• Must be able to work in a cross-functional environment to interact with multiple departments
• Prior experience in writing stability analysis and documentation
• Prior Stability experience with a minimum of 2 years of direct hands-on work with Stability in a GMP laboratory is required.
• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Bend, stoop, and carry
• Repeating motion that may include wrists, hands, and fingers

Work Hours & Schedule:

• Exempt Position
• Monday-Friday

• Minimum of 40-45 Hours Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Laboratory experience: 2 years (Preferred)

Work Location: One location

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