QC Operations Manager (FTC)

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

QC Operations Manager at AAMF QC, will play a key role in the operations of the AAMF QC labs. This role will include management of compliance, trending, batch release, lab coordination and sample management. A crucial part of this role will be leading issue management within the Quality Control (QC) department. In this people leadership role, you will be responsible for overseeing a team of Subject Matter Experts (SMEs) in Chemistry and Microbiology dedicated to handling QC deviations, introduction of new products, trending and batch release.

YOU WILL BE RESPONSIBLE FOR:

The role of QC Operation Manager is required to support AAMF QC lab activities as follows:

• Leading Issue Management. Oversee and lead the team of SMEs responsible for handling QC deviations. Provide guidance and support in resolving complex analytical issues and approval of these quality records.
• SPS Sessions and CAPA Identification. Lead with support of the team to facilitate SPS (Structured Problem Solving) sessions and identify Corrective and Preventive Actions (CAPAs) to address quality issues.
• Collaborate with cross-functional teams, including ADQC, External QC, QA, PQL/PTLs, site Technical Services and Alexion Technical Operations to gather inputs and assess analytical and product impact.
• Support the implementation of CAPAs as required, ensuring timely and effective resolution of identified issues and meet all regulatory requirements.
• Responsible for on time EM batch release
• Manage monthly, quarterly and annual trends
• Lead the introduction of new products into AAMF QC
• Responsible for sample shipments externally and management of raw materials.
• Oversee lab coordination activites including scheduling, document coordination and PO’s
• Work towards maintaining audit readiness by creating investigation storyboards, ensuring comprehensive and timely closure of investigations.
• Support generation and review of APQR’s. Support generation and/or review of LIR Quarterly Trending reports and Quality Management Review (QMR) metrics.