Tolmar · 15 hours ago
QC Associate I - Incoming
Windsor, CO
Full-time
Onsite
New Grad, Entry Level
$19.62/hr - $19.62/hrTolmar is a company focused on quality control in the pharmaceutical industry, and they are seeking a QC Associate I - Incoming to ensure the quality of incoming materials and components. The role involves sampling, inspection, testing, and release of materials while supporting overall quality activities across multiple facilities.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
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
Preferred
Associate's degree or college level courses preferred
Experience in a high volume manufacturing environment or laboratory is preferred
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
Founded in 2006
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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