QC Analyst II
The QC Analyst II position is a highly experienced analyst position within the QC laboratory. The QC Analyst II performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner. The QC Analyst II requires the least comprehensive in-house training curriculum of any analyst position in the laboratory by virtue of prior experience, although documented proficiency is required for the execution of all activities. The QC Analyst II performs all activities according to approved written procedures. Because of the level of experience associated with this position, a QC Analyst III may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, equipment IQ, OQ, PQ activities, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst II will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of quality control supervisory staff.
* Perform testing in accordance with written procedures for: stability samples, raw materials and packaging components, in-process manufactured material, and finished product (bulk or packaged)
* Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices
* Processing of electronic data using procedures that ensure data integrity and security
* Ship samples to contract testing facilities
* Review and approve results of raw material tests from contract laboratories
* Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations
* Transcribe results onto analysis reports
* Perform daily standardization and performance verifications on laboratory equipment
* Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security
* Identify deviations to written procedures. Write deviation investigation reports
* Disposal of laboratory waste on an as needed basis
* Identify and report unsafe conditions within the laboratory
* Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing and write investigation reports
* Perform testing to support method validations, method transfers, process and cleaning validations
Required Education and Experience:
* Bachelor's degree in Chemistry or related scientific field
* 3+ years of laboratory experience in a regulated environment
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Employer's Job# 10545
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