Quality Control Review Resource
Job Responsibilities:
- Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports.
- Performs data integrity review of CMC data and reports intended for regulatory filings.
- Ensures integrity, accuracy, and consistency of data and documents.
- Record QC metrics per defined categories.
Skills:
- Excellent oral and written communication skills.
- Experience working under GxPs and/or knowledge of GMP, ICH, USP and global compendial regulations and guidance.
Education/Experience:
- BA/BS or equivalent with typically 3+ years relevant experience in a biotechnological and/or pharmaceutical Quality Assurance setting.
- Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products.
- Ability to perform and verify mathematical determinations utilizing both calculator and computer programs, such as MS Excel.
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
- Previous experience with cell therapy development or cell-based assays (technical or quality review).
Recommended Jobs
Full-time Personal Chef - Waltham, MA
Job Description Job Description Description: ***Currently offering a sign-on bonus of $1,000 after 90 days Are you a culinary professional looking for more work-life balance and career growth …
Exam Room Assistant
Back Bay Veterinary Clinic is looking and we want to hire you! If you are obsessed with furry creatures as much as we are, then you are ABSOLUTELY perfect for the job. We are passionate about buildin…
Shipping & Receiving Coordinator
Position: Shipping and Receiving / Admin Support FLSA Status : Non-exempt Supervisor: Site Management Location: Wakefield, MA A unique opportunity to join a small stable company. Inn…
Senior Engineer II, Manufacturing Science and Technology
Job Description Job Description Description: Welcome to an inspired career. At Halozyme Hypercon™, a wholly-owned subsidiary of Halozyme Therapeutics, Inc. , we are reinventing the patien…
PART-TIME ACCOUNTING & OFFICE ADMINISTRATIVE ASSISTANT
Job Description Job Description Description: Accounting and Office Administrative Assistant We are seeking a dedicated and detail-oriented Accounting and Office Administrative Assistant to …
Personal Care Assistant PCA - 1965934
Job Description Job Description Our client, a family owned & reputable Home Care agency, with multiple offices in Massachusetts, is seeking compassionate, competent & dependable Personal Care As…
Histology Technician
Gastro Health is seeking a Part-time (PRN/ Per- Diem)Histology Technician to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of co…
Tech Con - Tech and Platforms - Risk Tech - SAP Controls - Manager - Multiple Positions - 1728229
At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and h…
SAP ERCS Associate Director
Accenture is a leading solutions and services company that helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across…
Anesthesiologist
ANESTHESIOLOGIST Department of Anesthesiology POSITION OVERVIEW Anesthesiologists at Boston Medical Center ensure patient safety and well-being throughout surgery by providing individual…