Join to apply for the QC Associate I - Incoming (Temporary) role at Tolmar
1 month ago Be among the first 25 applicants
Join to apply for the QC Associate I - Incoming (Temporary) role at Tolmar
Purpose and Scope
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 across multiple facilities.
Responsibilities include:
- Inspect incoming materials, components, and finished products against specified requirements.
- Perform physical or dimensional testing on incoming materials to ensure compliance with standards (e.g., ISO, ASTM), using inspection equipment such as calipers, micrometers, and optical comparators.
- Document all results following cGMP, ALCOA+, and data integrity policies.
- Enter data and results into LIMS.
- Review Certificates of Analysis (COAs) and Certificates of Compliance (COCs) for all incoming materials, including APIs and excipients, for compliance prior to release.
- Release products in Tolway for use in production.
- Follow procedures for determining status or disposition, document results properly in records and laboratory notebooks.
- Perform damage assessments and escalate quality defects as needed.
- Manage inventory requisitions and material holds related to deviations or expired materials.
- Identify non-conforming materials, segregate rejected materials, and determine retesting requirements.
- Ensure proper handling, storage, and traceability of approved materials.
- Perform inspections, documentation, and release of controlled supplies, ensuring their integrity and sterility.
- Support aseptic production by releasing nitrogen as needed.
- Review logbooks and documentation to support room cleans.
- Assist Materials Management with inspections and sampling.
- Complete required training (CBTs, data integrity, safety) and cross-train on related functions.
- Maintain training records.
- Ensure proper storage and status of materials and products.
- Sample materials for outside departments and support stat requests.
- Update and review SOPs and work instructions.
- Manage collection and disposal of retain samples.
- Generate document change requests and initiate deviations for non-conformances.
- Attend T3 academy and participate in process improvement initiatives.
- Perform cleaning, monitoring, and calibration of equipment.
- Collaborate with supplier quality to resolve material issues.
- Monitor equipment and facilities for proper operation.
- Participate in monthly quality and safety walkthroughs.
- Cross-train in other QCC systems and processes.
- Wash and dry glassware and support laboratory operations.
- Participate in annual hazardous waste training and respond to spills.
- Perform other duties as assigned.
Core Hours: Monday - Friday, 8:00 am - 4:30 pm
Qualifications:
- High school diploma or GED required; associate’s degree or college courses preferred.
- Experience in high-volume manufacturing or laboratory setting preferred.
Additional Requirements:
- Acceptable MVR, ability to lift 30 pounds, pass physical and eye exams, and see color.
Working Conditions: Office, warehouse, lab, and manufacturing environments; may require extended hours and travel between facilities.
Compensation & Benefits:
Tolmar is an Equal Opportunity Employer. All qualified applicants will be considered without discrimination based on protected statuses.