Alphanumeric Systems Inc.
Location
Cambridge, MA | United States
Job description
Alphanumeric is hiring a QA SPECIALIST – with CSV Programming ( Computer Systems Validation skills, Level 2 to work 1st shift in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. This is a Hybrid role for 9 months
We are seeking a skilled & experienced Sr QA Specialist to join our team. In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.
Responsibilities
- This role involves CSV (Validation programming) - according to regulations, standards and procedures. IMPORTANT SKILL!
- Support cross functional communication in all manners, work well in teams type of personality
- Support batch release of drug substance including compilation of documentation
- Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
- Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.
We are looking for professionals with these required skills to achieve our goals:
- High school grad with 8+ years of experience in a cGMP environment, OR associate degree and 6+ years of experience in a cGMP environment, Or bachelor's degree and 4+ years of experience in a cGMP environment.
- Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release,
- Preferred Qualifications:
- Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
- Demonstrated experience in regulatory inspection activities.
- Ability to work on multiple projects on a tight timeline.
- Ability to prioritize and the flexibility to adapt to changing priorities.
- Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- SAP knowledge, Vaccines knowledge a plus.
Good opportunity with great pay - apply today!
About Alphanumeric Systems Inc.: Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!
Job tags
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