Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QC Associate for our client in Devens MA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you are up to the challenge, then take a chance at this rewarding opportunity!
Shift: Overnight shift on a rotating schedule and will require weekends.
Shift is 5 PM_5AM, 2 days on / 2 days off, 3 days on / 2 days off
- This position will perform routine testing including Facilities (Water/Gas), STAT testing (In support of Manufacturing), and sample receipt functions.
- Primary responsibilities include testing of Abatacept using HPLC, UV-Vis, ATKA, Sialic acid, water testing (TOC, Conductivity, and Nitrates), and performing Sample Receipt functions.
- Other analytical support as needed.
Detailed Position Responsibilities
- Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional Medical Surveillance Teams (MSTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams.
- Creates meeting agendas for MST and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.
- Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.
- Assesses and appropriately elevates issues impacting key MST activities, milestones, documents to the appropriate Global Pharmacovigilance & Epidemiology (GPV&E) colleagues.
- Leads, plans, organizes, and forecasts requirements and/or resources based on Book of Work and other upcoming tasks and activities for assigned product portfolio.
- Executes searches of the corporate safety database, J-review database and the worldwide literature, applying critical thinking and independent research skills to ensure the information is appropriate and usable.
- Applies medical, life science and general scientific knowledge and expertise to create and manage plans and budgets for designated projects.
- BS with minimum of 3-4 years of experience in a GMP QC lab is required (or equivalent experience in a related biopharmaceutical GLP or GMP lab environment).
- Strong technical lab skills using pipettes, analytical balances, pH meter, etc. is a must. Experience with LIMS and Smart lab computer applications a plus.
- Proficient in common computer software applications, including Empower, and effective communication skills, both oral and written are needed.
- Candidate must have strong general laboratory and organizational skills, attention to detail, flexibility, and the ability to work as part of a team.
Interested in applying?
Contact Joy Retanan at (646) 695-2949 or at http://www.linkedin.com/pub/joy-retanan/85/4ba/333 or send your resume to Joy.Retanan@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.