13 days old


Kelly Services
Boulder, CO 80305

Temp to Hire

$32-$42 per hour

Work Hours- 4 day 10hr shift schedule (Wed Sat and Sun Wed; day and night shifts, 6AM 4PM and 4PM to 2AM).


Responsible for reference materials for the analytical chemistry testing laboratories. Coordinates the procurement, characterization, qualification, and requalification of reference materials. Incumbent is responsible for ensuring reference materials are available for cGMP analytical testing that support Research and Development, Quality Control, Manufacturing, and external clients.


+ Logging in Standards by assigning unique company numbers, determine amounts and/or tare weights, enter into Reference Standard Master Inventory

+ List including CoA and Expiration

+ Perform Qualification/Requalification activities including protocols, testing, reports, CoAs and expirations.

+ Responsible for the Stability Program

+ Coordinates study initiation, pull schedule, packaging, labeling, analytical testing, laboratory investigations, and compilation of stability data and results

+ Accountable for confirming that stability samples are properly packaged, exposed to the appropriate conditions, tested, and reported as dictated by cGMP

+ Stability Provide testing for development and commercial stability testing at both CPC and CPB, Data Review (Notebook & LIMS)

+ Initiating Stability Reports and Protocols

+ Pull Schedule, Tracker, and LIMS templates, results, and data review

+ Provide 24/7 coverage for analytical testing support for process development trials and manufacturing of development projects especially off hours

+ Proven experience in chromatographic analysis, analytical instrumentation theory, and practice, and wet chemistry techniques

+ Proficient in testing stability, reference standard qualification, and in-process control samples, reporting data, and data review

+ Understands the stability program and cGMP practices

+ Package stability samples with the appropriate verified materials

+ Understands the reference standard programs as it relates to general usage

+ Ability to trouble shoot basic problems on instrumentation and methods

+ Perform testing under full cGMP compliance and good documentation practices including notebook and LIMS entries

+ Provide analytical support for in-process control testing on a 24/7 basis

+ Perform cleaning sample testing to ensure that manufacturing equipment is clean and ready to be used for the next process

+ Under supervision conduct Laboratory investigations into any LIR, Deviation, OOS/OOT data generated with the objective of determining the root cause and establishing proper corrective and preventative actions

+ Familiar with common analytical techniques used by the S&S team such as: HPLC, GC, FTIR, UV/Vis, KF titrations, and other wet chemistry techniques

+ Perform testing using T-Methods for IPCs, Stability, and Standards Not yet validated or finalized

+ Keeps accurate records and documents experimentation

+ Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the company stability program

+ Participates in manufacturing site activities, such as troubleshooting and analytical problem resolving

+ Develops an understanding of QEH&S principles and regulatory affairs

+ Analyzes batches of drug substance and/or intermediates to be used in clinical or registration programs.

+ Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Bachelors degree in chemistry or related sciences with minimum of 2 year of cGMP/GLP laboratory experience.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Kelly Services
Boulder, CO 80305

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