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Quality Control Analyst II

s:
Quality Control Raw Materials is responsible for the activities at Operations Center by the inspection, sampling, and disposition of in-coming raw materials used in the manufacturing processes throughout the organization.


POSITION OVERVIEW/KEY RESPONSIBILTIES :
As a member of the Quality Control Raw Materials (QCRM) department, a Quality Control Analysts II will be expected to successfully execute the responsibilities relating to the quarantining, sampling, testing, inspection and disposition of all raw material lots received by the quality control raw materials department. These activities include Chemical raw materials, component inspection, and final packaging. In addition to lot release activities, a QC Analyst II is expected to participate in the mentoring and training of new analysts.

Responsibilities:
Demonstrate proficiency in a task by the completed of an On the Job Training. Maintain proficiency training per curricula on all governing procedures.
Perform all aspects of QCRM responsibilities as it pertain to release activities that will include but is not limited to the quarantining, sampling, testing, and disposition of raw materials and final packaging/component lots.
Support additional areas of QCRM including Rejected, Quality Hold, and Non-conforming materials.
Perform all activities adhering to strict cGMP guidelines.
Maintain on-time completion of all training requirements.
Perform simple laboratory instrument up keep including the cleaning, calibration, and the preventive maintenance of the instrument as outlined within the departments governing procedures.
Perform high level troubleshooting activities.
Participate in audit readiness.
Mentor and Train junior analysts.
Participate in department initiatives to support the continuous improvement of the quality systems of the QC Raw Materials department.
Practice safe work habits and adhere to safety procedures and guidelines.

Skills:
Experience with raw materials inspection and disposition.
Experience working within a cGMP environment.
Ability to prioritize and successfully manage multiple competing activities.
Must be able to lift up to 50 lbs.
Flexibility and ability to adapt to a dynamic work environment.
Work independently with direction from management.

PREFFERED Qualifications:
Able to work in a fast paced environment
Strong customer service orientation
Experience with Lims, Trackwise, MFG/PRO and Microsoft office
Experience working in a laboratory setting
Experience working in a clean room environment
Experience operating a Powered Work Truck (PIT)
Education:
High School Degree with 4+ years of experience in a cGMP Quality Control department within a FDA regulated industry (drugs, biologics). Or a Bachelor's degree in scientific related field with 2+ years of experience.


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