Quality Control Analyst IV - Chelsea, MA

Acorda Therapeutics is a publicly traded (NASDAQ: ACOR) biotechnology company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.

Acorda Therapeutics is a world leading biotechnology company focused on developing therapies that improve lives of people with neurological disorders. Acorda has a manufacturing facility in Chelsea, MA. The lead product in this facility is for the treatment of Parkinson’s disease. This product is in phase III of development and could profoundly increase the ability for many Parkinson’s patients to live relatively normal lives. The Quality Control Analyst IV is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This individual conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures. The Quality Control Analyst IV compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results. The Quality Control Analyst revises and updates standard operating procedures as needed.

* Operates analytical instrumentation including 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, alerting and proposing solutions to issues on instruments and/or test executions; leads and implements recommended solutions and/or corrective actions. * Independently organizes work flows to accomplish objectives, provides guidance and support to colleagues as needed, promotes new policies and programs tactfully and authentically, and may author/document performance reviews and/or evaluations.

Education and/or Experience: * Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required. * Minimum of 5-8 years of experience in a cGMP regulated environment required. * Must have experience with HPLC or UPLC * Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred. * Experience supervising, training or mentoring analysts is preferred. Qualifications: * 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 projects and/or teams independently * Ability to 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. Computer Skills: * Experience with MS Suite Certificates, Licenses, Registrations: * none required Other Skills and Abilities: * Excellent oral and written communication skills. * Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities. * Demonstrates dedication to documentation/data traceability and strong attention to detail. * Demonstrates appropriate safety consciousness.