QC Analyst III - Commercial Quality

QC Analyst III - Commercial Quality Job Description:Company Information:Breakthrough Careers!A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:This position is a key member of the Commercial Quality organization with responsibility for oversight of multiple vendor test laboratories in both domestic and international locations. Technical areas include in-process testing, release, and stability data review for both API and dose-form of small molecule and biologic drug products.Core responsibilites include atypical and OOS investigations, method transfer and implementation, and ongoing vendor relationship managment.Duties and Responsibilities:QC testing data review of small molecule analytical methods and bioassays generated by vendor test labs. Data review will include all or some of the following: HPLC, Gas Chromatography, Karl Fischer titration, UV Spectrophotometry, FTIR, Endotoxin LAL, Sterility, Bioburden, Cation-Exchange, Isoelectric Focusing, SDS-Page, SEC, Binding Efficacy, ELISA, Residual CHO DNAData Management:. Resolving observations, corrections to GMP documentation, troubleshooting. Verifying that data meets current specifications. Generating requisite COA(s), cycle time metrics. Entering results into QC database, and assembling QC data packages for batch file. Capturing related deviations, OOS, CAPAs, atypical results, change controls. Trending release testing data (graphical analysis)Vendor management:. Serving as primary QC representative on weekly conference calls to support batch release of Drug Products and Drug Substances. Maintaining ongoing communication with supplier QC counterparts. Coordinating delivery of release testing documentation (instrument printouts, chromatography, laboratory notebook pages, etc.). Monitoring stability test points, providing data to Commercial Stability group. Ensuring that supplier product-specific test methods and material specifications are consistent with Millennium documents. Attending semi-annual/quarterly performance meetings at each vendor site to present metrics, review major projects, and address ongoing issues. Supporting new initiatives, process improvements, and product investigationsTechnical Writing:. Change Controls, present to change control review board. CAPAs, consult scope of proposed action with QA Excursion group. Atypical and OOS investigations, collaborate with QA and/or Technical Operations group as needed. Authoring, reviewing, and revising CQC SOPs; Annual Product Review; QC sections for regulatory filingsQualifications:Basic Qualifications: Bachelors degree and 4+ years experience including at least 2 years of hands-on experience in a laboratory setting and 2 years in QC or cGMP compliance-related field. Experience may be substituted for MS degree.Preferred Qualifications: 4+ years of cGMP compliance experience with a solid understanding of applicable regulations and guidances, especially related to biologics. Strong communication and writing skills. Job related experience in QC specific to release testing review and assessment of deviations/investigations. Ability to collaborate effectively with various cross-functional groups within the company as well as with external vendors. Computer skills preferably include Word, Excel, Trackwise or electronic document repositories. This candidate must be flexible and motivated to support aggressive timelines and changing priorities.Click here to immediately applyWant to learn more about us? Years of Experience Required: 3-5 YearsExpected Travel Time: None Searchable Keywords: SAS / gj-moExpected Travel Time: None Company: Millennium Pharmaceuticals, Inc. Contact: Recruiter Email: Apply by Email Address: 02454 Reference Code: 14467.26412.5535BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science