QC Associate I - Incoming

Tolmar•Windsor, CO

6h•Onsite

About The Position

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

Requirements

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.
High school diploma or GED required.
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.

Nice To Haves

Associate’s degree or college level courses preferred.
Experience in a high volume manufacturing environment or laboratory is preferred.

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.