Manufacturing Technician I - Aseptic (D Shift)

TOLMAR Inc. • Windsor, CO • 17h ago

Description

Core Hours: Monday - Friday, 7am - 4pm

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

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 skills.

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

The Stability Associate I is expected to operate within the framework of Tolmar's 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 combination of education and experience.

One or more years of 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.

Compensation and Benefits

Pay: $23.00 - $25.00 per hour, depending on experience

Benefits summary: https://www.tolmar.com/careers/employee-benefits

Please note that due to the temporary nature of this position, not all benefits will apply

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.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesApply at: http://ipc.us/t/D28BEC09D1E84433.

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