Stability Associate II

Tolmar Inc.; Windsor (CO); Hybrid; USD 36,000 - 40,000; Full time

Job summary

Tolmar Inc. is seeking a Stability Data Technician to maintain the Stability System II Software, stability databases, and related records. This role supports compliance with cGMP and ISO9001, ensuring data integrity and timely reporting for regulatory submissions.

Responsibilities include entering new lots, accepting samples, auditing data, and writing stability protocols and reports. A bachelor's degree in a scientific field and 2+ years in pharma/medical device are preferred, with hybrid work

Qualifications

• 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.
• 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.

Skills

cGMPs & ISO9001

Word & Access

Communication

Attention to detail

Independent work

Team collaboration

Data auditing

Education

Bachelor’s degree in scientific discipline

Two+ years pharma/medical device experience

Tools

Stability System II Software

Stability databases

Job 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, assistance in writing stability protocols and reports, 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.


• 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.

Knowledge, Skills & Abilities

• 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.

Core Values

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.


• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.


• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity,inclusion& sustainability in our workplace.


• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.


• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• 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.


• Experience with quality or stability is desired.

Working Conditions

• Working conditions are generally office environment, but may also include outdoors, lab and warehouse environment. Work may require occasional weekend and/or evening work.


• The opportunity to work hybrid may be available based on performance.

Compensation and Benefits

• Pay: $26.00 to $29.00 per hour, depending on experience


• 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. 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.