Quality Control Analyst II

Position Summary

:

We are currently looking for a QC Analyst II to perform analytical testing of raw materials, finished product, stability samples, and R&D materials as part of the quality team. Additional requirements will include understanding the basics of proteomics and DNA, handing sensitive materials, performing statistical analysis on results, and technical writing to report results as part of supporting multiple departments to achieve a common goal. Level commensurate with experience.

Key Job Responsibilities:

• Complying with cGMPs, CLIA regulations, SOPs, safety requirements, and all company policies and procedures
• Take ownership of and responsibility for analytical testing, including method development or optimization as needed
• Generating and maintaining laboratory data and records in accordance with company policies
• Assist in designing product stability testing and writing testing protocol
• Analytical analysis of material to determine molecular weight, purity, amount, and other parameters as required. Testing may be performed in support of multiple working groups
• Independently perform and adequately document basic investigations for out-of-specification or out-of-trend results
• Assisting or leading the execution / implementation of larger projects, including revising/improving test methods, SOP revisions, process improvement projects, etc.
• Drive towards delivery of data and meeting deadlines, take ownership of associated tasks
• As appropriate, will cross-train in other departments or job functions to meet production or assay timelines when needed
• Participates in departmental or cross functional projects

Skills & Requirements

Qualifications:

Education:

Bachelor’s Degree – major in chemistry or related science is required

Skills and experience:

• 3 - 7 years of experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industries, working under cGMP or ISO regulations required
• Ability to test raw materials, in-process materials, and finished products
• Experience with LC-MS, UPLC, spectroscopy, other instrumentation
• Devise solutions for complex problems and execute to completion
• Effectively prioritize and meet deadlines, ability to multi-task effectively
• Learn to use new software as it relates to job function
• Strong communication and presentation skills, including technical writing and reporting
• Ability to build and maintain effective relationships across departments and working groups
• Proficient in MS Office applications, highly proficient in Excel

Work Environment:

• Ability to work in a fast-paced environment
• As SomaLogic is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations
• Works in a laboratory setting. The individual will be required to enter production support areas and laboratories while wearing appropriate PPE (personal protective equipment) such as lab coat, gloves and safety glasses. Note: Potential to work in proximity to patient samples, including blood, plasma, CSF, and other matrices, including known and suspected infectious material.

Benefits:

At SomaLogic, we recognize the key to success is having empowered team members. We value our employees and aim to retain and attract talent by offering competitive benefits. One thing that sets us apart is that our medical, dental, vision, short- & long-term disability plans and life insurance premiums are 100% paid by the company. We also offer competitive paid time off plans, including a Discretionary Time Off plan for exempt US employees, which gives eligible employees more flexibility to take personal time off; there is no specific number of vacation days off per year, an eligible employee does not accrue vacation, and there is no accrued vacation time off “bank.” Employees utilizing DTO remain accountable for ensuring that they balance their personal time off with work performance expectations. Employees also receive 13 paid company holidays, 1 personal floating holiday, a volunteer day, and 10 sick days. In addition, we offer 401(k) matching at 4%, FSA’s, tuition reimbursement, stock options, and an employee assistance program.

EEO Statement:

SomaLogic provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

IT Security Message:

Please beware of job offer scams using SomaLogic’s name targeting individuals who are actively seeking employment. SomaLogic will never send unsolicited job offers to job seekers, ask for any type of payment from potential candidates, or correspond with candidates from a non-Somalogic.com email address