SRG, the leader in the Life Sciences human capital industry, is looking for a contract QC Analyst (Lab) in Lexington, MA. Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

JOB RESPONSIBILITIES include, but are not limited to:

• 40-50% Testing execution, participate in training analysts, trouble shooting of methods
• 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
• 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Previous experience in a GMP QC role is preferred
• Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding

WHAT YOU NEED TO HAVE:

• Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
• Ability to work around chemicals (if working around the laboratories)
• Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
• Ability to walk and stand for periods of time
• Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Education:

Typically requires a bachelor's degree and a minimum of 5+ years of related experience. (science related degree is preferred)

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

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