QC Analytical Analyst I

 

Contribute to the creation and distribution of treatments that enhance lives. Make medicines more accessible. And help breakthroughs break through faster. At Curia, a global contract research, development, and manufacturing organization, our impact is real. So is your opportunity for a significant, satisfying career. As an employer of choice supporting the top 10 pharmaceutical companies, we offer numerous career advantages. In addition to competitive pay and meaningful benefits, you’ll enjoy the empowerment to be the difference, the chance to work with a diverse team of talented people, a culture that inspires success, and an award-winning workplace. Stop waiting for your future to arrive. Shape it every day with Curia.

 

We are rapidly growing and seeking a talented individual to join our Quality Control Team (QC) as a QC Analyst I. The role will report directly to the Associate Director of QC and will be based in our Hopkinton, MA facility. The ideal candidate will support cGMP validation and routine release testing for raw materials, in-process, drug substance and finished product testing for products produced at the Hopkinton GMP manufacturing facility.

 

Responsibilities

 

The ideal candidate will support cGMP method validation, equipment validation, qualification and release testing for raw materials, drug substance and finished product testing for products produced at Curia Global, Hopkinton GMP manufacturing facility and affiliated contract organizations. The individual will have a focus on Chemistry, Molecular, and Bioassay analytics, including HPLC, SDS page, ELISA, potency, IEF SEC and PCR.  The successful candidate will be able to work with guidance to execute SOPs and be able to perform routine testing in the QC Laboratory. He/she will help run methods and equipment and support investigations for OOS and other non-conforming results. He/she will contribute to the implementation of testing capabilities, related validation and qualification activities, investigations and assay/instrument troubleshooting with supervision. The individual will work with various groups including Manufacturing Sciences and Technology, Quality Control, and Quality Assurance. The candidate will have basic knowledge of cGMP principles, ICH, USP, FDA and EU guidance documents, and quality systems. Additional responsibilities include:

• Support execution of GMP QC methods, such as HPLC/UPLC, qPCR, ELISA, Potency, SDS Page, HPLC, CE, SEC, IEF and Cell-Based Assays (CHO) as needed 
• Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements 
• Assist in equipment qualification / validation activities, including maintenance 
• Provide support to QC management, including routine testing
• Perform general laboratory support activities including reagent preparation, equipment maintenance, etc. 
• Have a good understanding of laboratory instrumentation.
• Must be able to communicate effectively with supervisors and peers.

Requirements

• BS required in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science
• 0-3 years Quality Control experience in a cGMP organization 
• Experience with HPLC/UPLC chromatography 
• Knowledge and/or hand of experience in Bioassays (CHO), ELISAs, qPCR, and other molecular biology techniques. 
• Demonstrated knowledge of method and equipment 
• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way 
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment 
• Excellent communication skills (verbal and written), and other electronic systems

To be successful in this role you will need general knowledge of cGMP for biologics, ability to track and complete multiple priorities in a dynamic environment with supervision.  You’re resourceful, organized and a clear communicator.  You’re even-keeled, upbeat, responsive and thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. You have the ability to develop productive relationships with key stakeholders, good conflict management and negotiation skills. 

 

If you are looking for an opportunity to provide challenge and growth and this role excites you please Apply Today!

All interested applicants must apply online.  Curia is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

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