Quality Assurance Specialist, Manufacturing
Our client is revolutionizing the pharmaceutical industry and is looking to hire a highly skilled professional for the role of Quality Assurance Specialist, Manufacturing in Cambridge, Massachusetts. The Quality Assurance Specialist, Manufacturing will perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufacturing. This position is focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues. The company has one of the strongest reputations in the clinical business to add to your career and resume.
- Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition
- Performs batch and supporting documentation review
- Supports GMP compliance with time spent in the Manufacturing environment on a regular basis
- Analyzes and interprets projects, studies, or investigations to determine next steps
- Identifies, investigates, and resolves complex technical issues using problem-solving skills
- Reviews deviations, investigations, and CAPAs associated with cGMP compliance
- Writes new documents and revises existing documents, independently
- Performs QA review and approval of controlled documents
- Participates in internal or supplier audits
- Develop and provide training on department-specific procedures and systems
- Identifies and proposes Quality Process and system improvements
- Minimum of 5 years of experience in Regulated (food, medical device, or pharma/biotech) industry
- Must have direct experience with Quality Assurance within the Life Science industry
- Maintains current understanding of global GMP regulations
- Must be able to read, write and converse in English
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- Bachelor’s Degree in any Life Science discipline preferred
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.