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System One Quality Control Analyst II in Chelsea, Massachusetts

Quality Control Analyst II

Employment: Temp to Hire

Hours: Mon-Fri 8AM-5PM


• Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required.

• Minimum of 2-5 years of experience in a cGMP regulated environment required.

• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.

Knowledge/Skills Requirements:

• Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.

• Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required.

• Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.

• Experience with analytical method development and validation preferred.

• Familiarity with executing Standard Operating Procedures in a GMP setting required.

• Chromatography skills using Empower and/or ChemStation required.

• Critical understanding of the importance of documentation and data traceability required.

• Working knowledge of cGMP’s and their application to Quality Control required

Essential duties and Responsibilities include the following:

• Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction)

• Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).

• Statistically and critically analyzes data for trending and reporting into regulatory filings.

• Participates in Laboratory and/or Quality Investigations.

• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.

• Participates in the construction and/or revision of SOPs.

• Assists in the writing and updating of analytical test procedures, protocol, log books and checklists.

• Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.