Supplier Quality Engineering Specialist I

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

A higher level position may be considered depending on experience

Purpose and Scope

The Supplier Quality Engineering Specialist I is primarily responsible for supporting supplier quality related processes including Contract Manufacturing/Packaging Organizations (CMOs/CPOs). This position also supports site inspection readiness activities.

Essential Duties & Responsibilities

• Support the Supplier Change Notification Program, including completion of impact assessments.
• Own supplier-related quality events (deviations) and supplier corrective action reports (SCARs), including completing investigations and collaborating with technical subject matter experts and suppliers.
• Support the supplier complaint process as assigned.
• Support quality agreement program, including initiating and coordinating quality agreements with suppliers and other third parties.
• Support supplier audit program as assigned.
• Support supplier qualification and re-evaluation programs, including performing historical quality reviews, impact assessments, risk assessment and completing summary evaluations.
• Submit and monitor revisions to current department procedures.
• Assemble, review and submit supplier quality information to APQR team for annual reports.
• Perform supplier site visits to assist with supplier investigations as assigned.
• Support audit and inspection readiness activities, including providing training on associated processes/concepts to all levels of employees.
• Support post-audit and inspection activities (e.g. coordinating meetings, compiling data, etc.).
• Assist in preparing for and hosting external audits and inspections (FDA, Notified Body, Marketing Partners, etc.) including serving as a scribe, request taker or a "back room" support.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Working knowledge of GMP/cGMP guidelines.
• Knowledge of QA concepts related to raw material and supplier management activities.
• Knowledge of QA concepts related to inspection readiness activities.
• Knowledge of change control process.
• Knowledge of deviation/investigation process, including investigator skills.
• Ability to clearly communicate (verbally & in writing) and work well with suppliers and employees at all levels.
• Ability to effectively collaborate with technical subject matter experts and suppliers.
• Procedure and report writing capability.
• Computer literacy in Microsoft Word, Excel, PowerPoint and others as required.
• Independent, organized, and able to schedule work with minimal supervision to meet schedule deadlines.

Core Values

• The Supplier Quality Engineering Specialist I is expected to operate within the framework of Tolmar's Core Values:

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  • 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 preferred; equivalent education and experience of two or more years of related experience with an Associate's degree in a scientific discipline allowed.
• One or more years of experience in the pharmaceutical or medical device industry required; two or more years of experience in Quality Assurance preferred.
• Supplier and raw material program management experience preferred.
• Audit experience, including supplier or internal audits and site regulatory inspections preferred.
• Inspection readiness experience preferred.

Working Conditions

• Working conditions are normal for an office environment. Some overtime may be necessary.
• Domestic travel may be required, with occasional international travel possible, up to 10% of the time.

Compensation and Benefits

• Annual pay range $70,000 - $75,000 depending on experience
  
  
  
  • If candidate exceeds qualifications, a level II position may be offered in which the pay range is $90,000 - $95,000
  
  
  
  
• 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.