QC Analyst I (Onsite)
Company: Tolmar
Location: Fort Collins
Posted on: October 23, 2024
Job Description:
DescriptionShift: Tuesday - Saturday, 8:00 am - 5:00 pm
Purpose and Scope
The Quality Control Analyst I is responsible for sampling,
inspection, testing, and associated record keeping of samples.
Performs routine testing of raw materials, cleaning samples, bulk
intermediate and finished product, and/or stability samples,
according to established regulatory protocols and procedures.
Essential Duties & Responsibilities
- Complete training and become proficient in basic preparation
techniques and analytical methods.
- Perform analyses on a variety of samples using basic
preparation techniques and analytical methods.
- Inspect and sample materials in accordance with specified
requirements. Determine appropriate sampling area and PPE
requirements based on material properties.
- Perform heating, mixing and sampling of raw materials using
laboratory and material handling equipment.
- Ensure proper status, containers, and storage of materials and
product.
- Review SOPs and work instructions using the electronic document
management system.
- Collect and retain samples in accordance with
procedures.
- Perform retest sampling.
- Pull additional sample requests or inventory requisitions for
items in inspection.
- Perform cleaning and monitoring of rooms and
equipment.
- Document all activities and maintain records in adherence to
good documentation practices.
- Maintain accountability for proper use and care of
instrumentation.
- Complete tasks on time and work to eliminate repeat
errors.
- Follow all procedures applicable to job functions to ensure
high quality of work.
- Prioritize tasks and performs job duties with minimal guidance
from management. Work to complete tasks in an efficient manner and
serve as a productive member of the department. Contribute to a
highly productive environment by avoiding distractions.
- Follow procedures to determine status or disposition, and
properly document results on records and in laboratory
notebooks.
- Ensure that company and regulatory data integrity guidelines
are consistently followed.
- Provide detailed accounts of testing performed to
investigators. Under the direct supervision of an investigator, may
perform investigational testing.
- Maintain accountability for promoting an atmosphere of
teamwork, cordiality and respect towards co-workers.
- Provide support to the department leadership with the
implementation of new systems, and continuous improvement efforts.
Generate new ideas to create efficiencies and improve processes;
willingly support 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.
- Interact respectfully with all other employees both inside and
outside of the department and members of management and show
interest in others' input and reasoning. Appropriately resolve
differences of opinion.
- Complete training in accordance with requirements and
timelines.
- 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
- Basic understanding of a government-regulated laboratory
environment, preferably for drugs and medical devices including
GMP, GLP, and ICH and their application to laboratory testing and
review processes and procedures.
- Basic understanding and familiarity in the use of USP, NF and
other compendia.
- Ability to use and maintain analytical laboratory instruments
such as HPLC, FTIR, GC, and UV-Vis spectrophotometers.
- Ability to interpret, understand and follow analytical
procedures and calculations.
- 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.
- Strong organizational skills and attention to detail.
- Skill in effective written and oral communication.
- Ability to work independently and properly prioritize tasks
with limited supervision.
- Ability to work well with employees at all levels and
departments.
- Ability to use critical thinking to address potential areas of
concern.
- Knowledge of computer systems for sample tracking, laboratory
equipment, raw data handling and storage.
- Ability to interpret, understand and follow analytical
procedures and calculations.
Core Values
- The QC Analyst I is expected to operate within the framework of
Tolmar's Core Values:
- Consistently operate with the highest standards of ethics and
compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is
at the heart of our company's success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
Education & Experience
- Bachelor's degree in scientific discipline, preferably in
Chemistry or Biochemistry.
- Previous experience in an analytical laboratory position
preferred.
- Experience in a high-volume manufacturing environment
preferred.
Additional Requirements
- Valid driver's license and Acceptable MVR may be
required.
- Ability to bend, squat, and lift minimum of 30 pounds
required.
- Ability to pass physical and eye exam required. Ability to see
color.
Compensation and Benefits
- Pay: $28.60 - $29.10 per hour, depending on experience
- Benefits summary:
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.
Working Conditions
- Laboratory setting. Will be exposed to solvents, bio-hazardous
materials, hazardous waste, and pharmaceuticals.
- Must be adaptable to shifting priorities and operate with a
sense of urgency while maintaining high quality in order to meet
important timelines in a high throughput lab.
- Business demands may present a need to work extended
hours.
- Working conditions are in an office, warehouse, laboratory and
manufacturing environment.
- Occasional overtime may be required.
- Work may consist of travel between multiple facilities.
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.Qualifications
EducationBachelors of Chemistry (required)
Equal Opportunity Employer/Protected Veterans/Individuals with
DisabilitiesThe 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)
Keywords: Tolmar, Thornton , QC Analyst I (Onsite), Professions , Fort Collins, Colorado
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