Stability Associate II

Tolmar Careers • Windsor, CO

1d • $26 - $29 • Hybrid

About The Position

Responsible for maintaining the following systems and/or databases: Stability System II Software, stability database, stability variances, stability environmental chambers, assistance in writing stability protocols and reports, data auditing and stability records.

Requirements

• Knowledge of cGMPs and ISO9001, with commitment to following written procedures.
• Proficient in use of Word and Access software programs, and ability to learn new software programs quickly.
• Effective oral and written communication.
• Organized, with high accuracy of work and attention to detail.
• Ability to work independently with minimal supervision to meet scheduled deadlines.
• Ability to work well with employees at all levels.
• Ability to audit data, review data and write reports.
• Valid driver’s license and acceptable Motor Vehicle record required.
• Bachelor’s degree in scientific discipline, math or science preferred, or equivalent experience.
• Two or more year’s experience in the pharmaceutical or medical device industry.

Nice To Haves

• Experience with quality or stability is desired.

Responsibilities

• Requisition, label and place stability samples into appropriate storage conditions according to approved protocols.
• Enter new lots into the Stability System II Software and stability databases.
• Pull samples at appropriate time points and deliver to the QC, AD and Microbiology Labs, as appropriate.
• Monitor chamber storage conditions per electronic monitoring systems and follow-up on any excursions.
• Audit stability data after data entry for accuracy & compliance to protocols.
• Review stability data to monitor product performance.
• Ensure that variances, aberrant results and incident reports are documented.
• Print graphs and data as required for investigations.
• Write stability protocols and reports for regulatory submissions.
• Accurately process Document Change Requests (DCR’s) and Product Change Orders (PCO’s) as required.
• Approve PCO’s after assessing impact to the stability program.
• Transport stability samples between company locations.
• Participate in required annual hazardous waste training.
• Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage.
• Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as required.

Benefits

• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level