Stability Associate I

Description

Shift Schedule

Monday - Friday, 8 : 00 am - 5 : 00 pm

Purpose and Scope

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

Essential Duties & 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, and audit study start documentation.
• Pull samples at appropriate time points and deliver to the QC, AD and Microbiology Labs, as appropriate.
• Enter raw data accurately into SSII and ensure that variance numbers, Laboratory Investigation (LI) numbers, Quality Event (QE) numbers and data notes are included in the interval comments, and ensure all required data are reported from QC and Microbiology per the protocol and variances.
• Update data tracking tools to monitor data status, and periodically notify team of pending data.
• Audit stability data after entry into database for accuracy & compliance to protocols.
• Review stability data to monitor product performance. Ensure that variances, aberrant results and incident reports are documented.
• Monitor chamber storage conditions per electronic monitoring systems and follow-up on any excursions.
• Assist in writing annual stability reports for regulatory submissions.
• Print graphs and data as required for investigations.
• Accurately process documents as required.
• 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.

Knowledge, Skills & Abilities

Core Values

This position is expected to operate within the framework of Tolmar's Core Values :

Education & Experience

Working Conditions

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.