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Quality Control Analyst I
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Based on Utah data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$70,720 / year median in Utah
-10% projected decline
Job Description
- Responsible for testing and analyzing incoming materials such as intermediates, finished products and swab samples.
- Responsible for preparing, maintaining and reviewing thorough records, documentation on solutions, sample preparation and investigational/experimental samples.
- Responsible for supporting laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
- Responsible for performing revisions to documentation such as Standard Operating Procedures, Test Methods and Specifications.
- Responsible for coordinating and sending materials for contract laboratory testing.
- Responsible for compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
- Responsible for performing verification of compendial methods.
- Responsible for providing training to other analysts on activities for which they have developed a level of expertise.
- Responsible for performing peer review on documents which may also become a full-time role.
- Responsible for assisting with activities associated with the stability program including sampling and statistical analyses.
- Responsible for assisting with activities related to the sampling of incoming materials as needed.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
Education/Certification/Experience:
- Requires a Bachelor's degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of 3 years relevant progressive experience in a Quality Control Laboratory environment.
- Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques.
- Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
- Prefer experience with Laboratory Information Management Systems (Labware LIMS and/or Empower preferred).
Have Skills/Knowledge/Abilities:
- Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.
- Ability to effectively document a process, explaining scientific and/or technical ideas in writing (technical writing skills).
- Ability to communicate effectively with excellent written and oral communication skills.
- Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
- Self-directed with ability to organize and prioritize work.
- Detail oriented with ability to identify errors and/or inconsistencies while performing tasks.
Problem Solving:
- Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.
- Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
- Selects methods, techniques, and evaluation criteria for obtaining results.
- Acts independently and proactively to recommend methods and procedures for problem resolution.
WORKING ENVIRONMENT
- Exposure to fumes, odors, dusts, mists or gasses (for non-office).
- Exposure to moving mechanical parts or moving equipment.
- Exposure to low to moderate to loud noise levels.
- May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.
Comprehensive Health Insurance:
Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.Retirement Savings:
401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.Time Off:
Paid Time Off including vacation, sick/safe time, caretaker time and holidays.Life and Disability Protection:
Company paid Life and Disability insurance.- Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.