Stability Associate II

Tolmar Careers•Windsor, CO

6d•Hybrid

About The Position

Responsible for maintaining the Stability System II Software, stability database, stability variances, stability environmental chambers, assistance in writing stability protocols and reports, data auditing and stability records. This role involves requisitioning, labeling, and placing stability samples, entering new lots into systems, pulling samples at appropriate time points, and delivering them to labs. The associate will monitor chamber storage conditions, audit data for accuracy and compliance, review data to monitor product performance, and ensure documentation of variances and incidents. Responsibilities also include printing graphs and data, writing stability protocols and reports, processing Document Change Requests (DCR’s) and Product Change Orders (PCO’s), and transporting samples between company locations. Participation in hazardous waste training and spill response is also required.

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.
Respond to spills per the Chemical Spill Procedures.
Perform other related duties as required.