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QC Associate I - Incoming (Temporary)

Tolmar

Windsor (CA)

On-site

USD 80,000 - 100,000

Full time

14 days ago

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Job summary

An established industry player is seeking a QC Associate I to ensure the quality of incoming materials and components. This role involves inspecting, testing, and documenting results to uphold rigorous quality standards. You will support multiple facilities in maintaining compliance with industry regulations and contribute to the overall quality assurance process. If you are detail-oriented and thrive in a dynamic environment, this opportunity offers a chance to make a significant impact in quality control while working alongside a dedicated team. Join us in our mission to deliver excellence in every product.

Qualifications

  • High school diploma or GED required; associate’s degree or college courses preferred.
  • Experience in high-volume manufacturing or laboratory setting preferred.

Responsibilities

  • Inspect incoming materials and components against specified requirements.
  • Document results following cGMP and data integrity policies.
  • Release products for use in production and manage inventory requisitions.

Skills

Material Inspection
Testing and Sampling
Data Entry
Quality Control Standards (ISO, ASTM)
Documentation Skills

Education

High School Diploma
Associate's Degree

Tools

LIMS
Calipers
Micrometers
Optical Comparators

Job description

Join to apply for the QC Associate I - Incoming (Temporary) role at Tolmar

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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.

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