Quality Assurance Operations Specialist Job Vacancy in Tolmar Inc. Windsor, CO 80550 – Latest Jobs in Windsor, CO 80550

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Company Name : Tolmar Inc.
Location : Windsor, CO 80550
Position : Quality Assurance Operations Specialist

Job Description : Purpose and Scope
The Quality Operations Specialist is responsible for providing technical quality oversight for Tolmar manufacturing operations in accordance with company policies, standards, procedures and current Good Manufacturing Practices (cGMP). Functional responsibilities will include supporting the design and implementation of quality systems for new manufacturing processes and continuous improvement of the quality systems within current manufacturing processes, especially within aseptic processing. They will serve as a quality point of contact for the operations teams and will use risk-based decision making to address any issues on the manufacturing floor. The position will also create, revise and review of documents that support the manufacturing operations, such as, standard operating procedures, work instructions, change controls and qualification documentation ensuring accuracy and appropriateness.
Essential Duties & Responsibilities

Demonstrate a high level of discretion in the timely identification and resolution of events potentially impacting the Quality of products and processes.
Work effectively with Operations, Maintenance, and Engineering to make immediate, risk- based decisions; escalate issues to QA management as necessary.
Follow all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function.
Responsible for providing Quality oversight to ensure that products are manufactured and stored in accordance with cGMP, other applicable regulations and internal company policies and procedures.
Support department supervision in oversight and prioritization of day-to-day responsibilities.
Provide quality support for deviations associated with operations determining immediate actions, assisting with investigation and assessing impact.
Create, revise and review documents: SOPs, work instructions, qualification documentation and other Quality documentation directly related to operations and other cGMP activities.
Independently lead projects to address quality gaps or drive continuous improvement for Operations or Quality Systems.
Implement risk based quality oversight program for Operations.
Develop standard work and ensure completion of routine activities within established timelines.
Support internal and external audits of Tolmar Quality Systems/Operations.
Assist the Compliance group with the performance of internal audits associated with manufacturing operations.
Represent department in internal and external cross-functional teams.
Perform observation of activities in a clean room environment requiring clean room gowning, including but not limited to:

Company-provided Scrubs
Shoe Covers and Sterile Boot Covers
Hairnets (and beard covers as applicable)
Tyvek/Sterile Coveralls
Gloves
Full-face masks/hoods
Goggles
Chemical Protection PPE

Perform other duties as assigned.

Knowledge, Skills & Abilities

Knowledge in cGMP, 21 CFR 210, 211, 820 and ISO 13485.
Independent, organized and able to lead others to meet deadlines.
Ability to work in an independent and self-directed manner.
Ability to clearly communicate (oral & written) and work well with employees at all levels.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Ability to write procedures and reports clearly and accurately.
Ability to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
Ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
Computer literacy in Microsoft Word, Access, Excel and other MS Office programs.
Recognized subject matter expert on quality assurance topics within an operations environment.

Core Values

The Quality Operations Specialist is expected to operate within the framework of Tolmar’s Core Values:
Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

Bachelor’s degree required, in scientific discipline preferred: engineering, microbiology, chemistry or biochemistry.
Five or more years of experience in the pharmaceutical industry working in a quality or manufacturing.
Experience in Aseptic manufacturing preferred.

Working Conditions

Core hours are from 8 AM – 5 PM Monday through Friday, with availability to work extended hours on evenings and/or weekends as necessary.
This position will work in an office area, as well as in manufacturing areas as needed.

Compensation and Benefits

Pay: $70,000 – $80,000 depending on experience
Benefits information: 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.

Experience Preferred

5 year(s): Pharmaceutical industry working in a quality or manufacturing

Education Required

Bachelors or better

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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