Quality Control Analyst
We are currently searching for a skilled professional to join a well-known client’s team as Quality Control Analyst in Cambridge, Massachusetts. The Quality Control Analyst position involves working with contract testing sites, performing method transfers and providing method troubleshooting support in addition to reviewing release and stability data. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Perform review and trending of release data, stability data, and process validation data for protein and biological products generated in house and by external vendors
- Perform investigation of OOS results, review deviations and CAPA reports
- Author stability protocols and reports, plan and coordinate initiation of new stability studies
- Collaborate with Regulatory Affairs on preparation of stability data for the regulatory submissions
- Perform method transfers and troubleshooting
- Provide analytical support and conduct investigations as needed
- Perform methods development and improvements
- Perform other laboratory tasks working closely with other departments that support Commercial Quality Control
- Review release and stability data
- Author technical documents, reports, protocols, SOPs
- At least 3 years in Quality Control or Quality Assurance
- Demonstrated cGMP analytical laboratory experience including HPLC, bioassays, ELISA, SDS-PAGE analysis
- Knowledge of SEC, CEX and CE, Cell Culture preferred
- A broad working knowledge of USP, EP, and FDA guidance documents
- Good understanding of cGMPs and quality systems and processes
- Good writing and verbal communication skills
- Master’s of Science with at least 3 years of experience
- Bachelor’s of Science with 6+ years of experience in QC/Analytical lab
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.