QC Associate I - Incoming (Temporary)

Core Hours

Monday - Friday, 8:00 am - 4:30 pm

Purpose and Scope

The Quality Control Associate I - Incoming is responsible for sampling, inspection, testing, and release of incoming materials and components. They also are the overall Quality support for receiving activities throughout multiple facilities.

Essential Duties & Responsibilities

• Inspect incoming materials, components, and finished product against specified requirements.
• Perform associated physical or dimensional testing on incoming materials including labels, cartons, syringes, containers etc. to ensure compliance with standards (e.g. ISO, ASTM).Operate inspection equipment (calipers, micrometers and optical comparators to evaluate product measurements.
• Document all results per cGMP, ALCOA+ and data integrity policies and procedures.
• Enter data and results into LIMS.
• Review COAs and COCs and other related documentation for all incoming materials, including APIs and excipients for compliance to the specification prior to release of the materials in Tolway for use in production.
• Releases product in Tolway for use in production.
• Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.
• Perform damage assessments for materials and escalate associated quality defects.
• Perform inventory requisitions for requesting departments.
• Place materials on hold in Tolway related to deviations and for expired materials.
• Determine which materials should be placed in a rejected status and segregate non-conforming materials
• Determine which materials require retesting.
• Ensure proper handling, storage and traceability of approved materials.
• Perform inspection, documentation and release of all controlled supplies ensuring the integrity and sterility.
• Perform release of nitrogen to be utilized in the aseptic production of Eligard and EPSS.
• Review logbooks, and documentation to support room cleans.
• Support Materials Management (Receiving and Issuance Personnel) with inspections and material sampling as needed.
• Perform required CBT's, annual data integrity and safety related trainings and cross train on all associated job functions to ensure adequate process coverage.
• Complete compliance training according to requirements and maintain training records in the electronic document system.
• Ensure proper status and storage of materials and product.
• Sample materials for outside departments, supporting stat requests as needed.
• Update and review SOPs and work instructions using the electronic document management system.
• Collection and disposal of retain samples in accordance with procedures.
• Generate document change requests for specifications.
• Initiate deviations, complete immediate actions and request assessments for non-conformances from appropriate groups (ie Packaging Engineering).
• Attend T3 academy.
• Support and participate in reduction in cycle time and cost savings initiatives.
• Perform cleaning and monitoring of rooms and equipment.
• Coordinate equipment calibration with the instrumentation team.
• Collaborate with supplier quality to resolve material quality issues or discrepancies.
• Monitor equipment and facilities for proper operating conditions.
• Participate in monthly quality and safety walkthroughs.
• Perform cross training in other QCC systems, processes and procedures including laboratory support, sample submission, logbook creation, inventory maintenance and glassware cleaning, stability sample pulls and submission to the laboratory.
• Wash and dry glassware and distribute to appropriate locations within the laboratory.
• 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 various other duties as assigned.

Knowledge, Skills & Abilities

• Working knowledge in drug or device cGMP.
• Knowledge of computer operations, including proficiency with MS Word, Excel, powerpoint, and Access.
• Ability to learn Tolmar's electronic systems.
• Skill in organization and attention to detail.
• Skill in effective written and oral communication.
• Work independently and properly prioritize tasks with limited supervision.
• Ability to work well with employees at all levels and departments.
• Ability to read, understand and follow procedures.
• Ability to identify non- conforming materials, processes and procedures.
• Demonstrate competency in technical writing.
• Ability to use critical thinking to address potential areas of concern.
• Proficiency in utilization of electronic data management systems.

Core Values

• The QCC Associate 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

• High school diploma or GED required.
• Associate's degree or college level courses preferred.
• Experience in a high volume manufacturing environment or laboratory is preferred.

Additional Requirements

• Acceptable MVR required.
• Ability to bend, squat, and lift minimum of 30 pounds required.
• Ability to pass physical and eye exam required.
• Ability see color.

Working Conditions

• Working conditions are in an office, warehouse, laboratory and manufacturing environment.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput environment.
• Business demands may present a need to work extended hours.
• Occasional overtime may be required.
• Work may consist of travel between multiple facilities.

Compensation and Benefits

• Pay: $19.62 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-benefits
  
  
  
  • Please note that due to the temporary nature of this position, not all benefits may 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.