QA Operations Specialist

Core Hours: Monday - Friday, 8am-5pm

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 sterile 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/approve quality records that support the manufacturing operations, such as, standard operating procedures, work instructions, change controls and investigations 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.
• Perform investigations for the Quality Operations team.
• Provide quality support and approval for deviations associated with operations and environmental monitoring excursions, 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.
• Coordinate/Manage Tolmar's program for Sterile Process Oversight.
• Develop standard work and ensure completion of routine activities within established timelines.
• Support internal and external audits of Tolmar Quality Systems/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:




• 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 required, in scientific discipline preferred: engineering, microbiology, chemistry or biochemistry.
• Five or more years of experience in the pharmaceutical industry working in 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

• Annual pay range $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.

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.