Quality Control Specialist I

Location
Cambridge, MA, United States
Posted
Sep 19, 2018
Ref
R-00316
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Quality Control Specialist I

Company:
Ipsen Bioscience, Inc.

Job Description:

Duties:

Write and execute validation and transfer protocols and reports under cGMP. Support multiple validation, verification and transfer projects both in-house and at contract organizations. Troubleshoot potential problems during validation and address and advise on issues such as deficiencies and discrepancies. Serve as a subject matter expert on various methods and technologies within Quality Control (QC) and with external groups and partners. Assist in method and equipment troubleshooting within QC. Support QC in developing SOPs, job aids, and training manuals as needed. Support continuous improvement initiatives utilizing quality systems such as CAPA, and Change Control, as well as lead and participate in laboratory investigations for quality incidents and deviations. Work closely and collaborate with Quality Assurance, Process Development, Manufacturing, and Research and Development teams.

Requirements:

Bachelor's degree (or foreign equivalent) in Biochemistry, or a related field; and five (5) years of post-baccalaureate work experience. Experience must include: Development, qualification and validation of HPLC-based test methods for proteins, lipids, and small molecules, as well as standard wet chemistry methods, in a cGMP environment; Transfer of analytical methods into and out of QC labs; Current regulations, guidance, and compendia (such as 21 CFR 211, ICH Q2, USP 1224 and 1225, and EP 2.2.46); GMP quality systems for continuous improvements, such as CAPA and Change Control; Particle sizing and zeta potential; HPLC techniques such as ELSD, UV, Fluorescence, and RI; Solid-phase extraction, dissolution, TOC, or standard wet chemistry methods.

To apply, please e-mail resume to Corey Mathison at corey.mathison@ipsen.com referencing job code 11926.5

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.