TOLMAR
QA Associate I - Incoming (Onsite)
TOLMAR, Windsor, Colorado, us, 80551
Core Hours
Monday - Friday, 8:00 am - 4:30 pm
Purpose and Scope
The Quality Assurance Associate I is responsible for sampling, inspection, testing, and record keeping of raw materials and components. They also are the overall Quality Assurance support for receiving and issuance activities throughout multiple facilities.
Essential Duties & ResponsibilitiesInspect material, components, and finished product against specified requirements.Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.Perform inspections on a variety of materials using measuring and test equipment.Support Materials Management (Receiving and Issuance Personnel) with inspections and material sampling.Training of associates on various job functions.Complete training according to requirements and maintain training records in the electronic document system.Ensure proper status and storage of materials and product.Provide materials to outside departments as requested.Update and review SOPs and work instructions using the electronic document management system.Complete review and release of components and labeling, including generation of COA through LIMS.Provide quality oversight of receiving and issuance processes.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).Perform cleaning and monitoring of rooms and equipment.Coordinate equipment calibration with Calibration Technicians.Monitor equipment and facilities for proper operating conditions.Participate in monthly quality and safety walkthroughs.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'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.Demonstrate competency in technical writing.Ability to use critical thinking to address potential areas of concern.Education
& Experience
High school diploma or GED required.Associate's degree preferred.Experience in a high volume manufacturing environment 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 to see color.Working Conditions
Working conditions are in an office, warehouse and manufacturing environment.Occasional overtime may be required.Work may consist of travel between multiple facilities.Compensation and Benefits
Pay: $19.62 per hourBenefits information: 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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Monday - Friday, 8:00 am - 4:30 pm
Purpose and Scope
The Quality Assurance Associate I is responsible for sampling, inspection, testing, and record keeping of raw materials and components. They also are the overall Quality Assurance support for receiving and issuance activities throughout multiple facilities.
Essential Duties & ResponsibilitiesInspect material, components, and finished product against specified requirements.Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.Perform inspections on a variety of materials using measuring and test equipment.Support Materials Management (Receiving and Issuance Personnel) with inspections and material sampling.Training of associates on various job functions.Complete training according to requirements and maintain training records in the electronic document system.Ensure proper status and storage of materials and product.Provide materials to outside departments as requested.Update and review SOPs and work instructions using the electronic document management system.Complete review and release of components and labeling, including generation of COA through LIMS.Provide quality oversight of receiving and issuance processes.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).Perform cleaning and monitoring of rooms and equipment.Coordinate equipment calibration with Calibration Technicians.Monitor equipment and facilities for proper operating conditions.Participate in monthly quality and safety walkthroughs.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'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.Demonstrate competency in technical writing.Ability to use critical thinking to address potential areas of concern.Education
& Experience
High school diploma or GED required.Associate's degree preferred.Experience in a high volume manufacturing environment 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 to see color.Working Conditions
Working conditions are in an office, warehouse and manufacturing environment.Occasional overtime may be required.Work may consist of travel between multiple facilities.Compensation and Benefits
Pay: $19.62 per hourBenefits information: 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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)