QC Analyst II (Onsite) jobs in United States
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Tolmar · 2 months ago

QC Analyst II (Onsite)

Tolmar is a company focused on supporting the well-being of patients and treating employees as valued partners. They are seeking a QC Analyst II to perform routine testing of raw materials and finished products while ensuring compliance with regulatory protocols and procedures.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods. Employee will be trained and become proficient in the intermediate preparation techniques and analysis methods
At the direction of management, train junior analysts in analysis methods and lab techniques
Accountable for documenting all activities and maintaining records according to good documentation practices
Accountable for proper use, care and maintenance of instrumentation
Perform intermediate method transfers
Provide detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing
Make scientific recommendations to management/technical writers regarding QC procedures
Completes tasks on time and works to eliminate repeat errors. Follows all procedures applicable to job functions to ensure high quality of work
Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner, and is a productive member of the department. Contributes to a highly productive environment by avoiding distractions
Employee is responsible for ensuring that company and regulatory data integrity guidelines are consistently followed
Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Willing to assist co-workers in the completion of tasks
Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary
Interacts respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning. Appropriately resolves differences of opinion
Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors
Identifies issues and escalates those issues to the department senior leadership or management as appropriate
Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements
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 additional duties as assigned

Qualification

CGMP knowledgeHPLCGLP knowledgeAnalytical laboratory experienceUSP knowledgeEffective communicationTeamworkProblem-solvingAttention to detail

Required

Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry
Two or more years of experience in an analytical laboratory position
Knowledge of a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures
Intermediate understanding of the use of USP, NF and other compendia
Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers
Effective written and oral communication skills
Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage
Ability to interpret, understand and follow analytical procedures/calculations and scientific principles

Company

Tolmar

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TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.

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 Stage

Leadership Team

A
Anil D'souza
Chief Executive Officer
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Gerald Wallner
Data Integrity Manager
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Company data provided by crunchbase