job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!
location: Andover, Massachusetts
job type: Contract
salary: $24.35 - 28.65 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- This role will provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).
- Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations
- Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans
- Develop, drive and perform comparability studies for implementation of analytical assays on new instrumentation.
qualifications: Education & Qualifications
- A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.) No PHD's
- Strong working knowledge of the validation life-cycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.
- Working knowledge of data integrity regulations, guidance, and principles
- Working knowledge of CAPA and change control processes
- Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.
- Knowledge and experience with a wide variety of analytical techniques including HPLC, UV/VIS, CGE, FT-IR and ICE.
- Past experience working with QC instrumentation in the bio-pharmaceutical field is preferred but not required.
skills: Quality control, HPLC, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.