Purpose and Scope
The Lead QC Associate - Incoming provides leadership and guidance for the Incoming inspection team. This includes scheduling/coordinating inspections, ensuring timely releases of materials, troubleshooting issues and performing inspections/material releases. The Lead QC Associate - Incoming helps to drive continuous improvement initiatives for the team.
Essential Duties & Responsibilities
- Inspect incoming materials, components, and finished product against specified requirements.
- Perform associated testing of incoming materials including labels, cartons, syringes, containers etc.
- Utilize measuring and testing equipment to evaluate product measurements.
- Document all results per cGMP, ALCOA+ and data integrity policies and procedures.
- Reviews COAs for all incoming materials, including APIs and excipients for compliance to the specification prior to the release of materials in the ERP for use in production.
- Prioritize daily group tasks, including scheduling of material inspections to ensure timely inspection, sampling and release of material.
- Communicate with the planning team regarding material needs and timelines.
- Perform inventory requisitions for requesting departments.
- Place materials on hold in ERP related to deviations and for expired materials.
- Determine which materials should be placed in a rejected status.
- Determine which materials require retesting.
- Perform inspection of all controlled supplies ensuring integrity and sterility.
- Review logbooks, and documentation to support room cleans.
- Identify and support improvements to streamline inspection and documentation processes and work with other departments involved to ensure success.
- Attend T3 academy.
- Perform required CBTs, annual data integrity and safety related training 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.
- Contribute to Competency Based Training (CBT) as a subject matter expert, acting in a Developer, Trainer and Assessor capacity.
- Update and review SOPs, specifications and work instructions using the electronic document management system.
- Provide quality support to associates for troubleshooting issues and escalate as required.
- Act as a lead or SME on investigations involving QC Incoming activities or processes.
- Coordinate monthly quality and safety walkthroughs.
- Initiate deviations, complete immediate actions and request assessments for non-conformances from appropriate groups (i.e. Packaging Engineering).
- Complete corrective and preventative actions as determined through investigations.
- Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.
- Support Materials Management (Receiving and Issuance Personnel) with inspections and material sampling.
- Ensure proper status and storage of materials and products.
- Provide materials to outside departments supporting status requests as needed.
- Collect and dispose of retain samples in accordance with procedures.
- Perform cleaning and monitoring of rooms and equipment.
- Coordinate equipment calibration with Calibration team.
- Demonstrate high level of proficiency in department job functions.
- Provide recommendations for quality decisions related to incoming inspection.
- Perform cross training in other QCC systems, processes and procedures including but not limited to laboratory support, sample submission, logbook creation, inventory maintenance, ordering and glassware cleaning.
- 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 and Access.
- Ability to learn Tolmar electronic systems (ERP, EDMS, EQMS and ELMS).
- Strong organizational skills and attention to detail.
- Strong written and oral communication.
- Ability to work well with employees at all levels and departments.
- Ability to read, understand and follow procedures.
- Strong technical writing skills.
- Ability to use critical thinking to address non-conformances and potential areas of concern.
- Ability to work independently and properly prioritize tasks with limited supervision.
- Ability to identify non-conforming materials, processes and procedures.
Core Values
The Lead QC Associate - Incoming 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.
Communication
- Interact with peers and members of other departments in team settings in a professional manner.
- Provide consistent coaching, guidance, development and mentorship to associates.
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.
- Five or more years’ experience in a quality-related capacity required. Experience in pharmaceutical or medical device industry 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 is required.
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.
- Work may consist of travel between multiple facilities.
Compensation and Benefits
- Pay: $32.00 - $33.50 per hour depending on experience
- Benefits summary: https://www.tolmar.com/careers/employee-benefits (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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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 (https://www.eeoc.gov/poster) notice from the Department of Labor.
