Join our client's primary focus in patient safety while adding value to its owners. By providing a large variety of frequently used compound medications, in bulk packaging, at very competitive rates, they are the best at offering quality, safety, and service standards. Come join our client's facility in Woburn, MA.
- Observes and follows cGMP principles.
- Collaborate with the production team which includes, pharmacists and technicians to provide QC/QA support and guidance where needed
- Consistently providing a daily status updates to the head of quality
- Reviewing and approving batch records, aseptic technique qualifications, and media fill process validations.
- Author and edits standard operating procedures.
- Performs pH testing
- BS degree in technical or scientific discipline with at least 8 years of experience in pharmaceutical or medical device FDA GMP environment with over 5 years of QC experience.
- Art least 8 years of QC Microbiology experience, including but not limited to EM, sterile processes, aseptic techniques, sterile gown qualification,
- Must have an in-depth knowledge of pharmaceutical manufacturing/controls, cGMP's, FDA regulations (21 CFR Parts 210, 211), and International Conference of Harmonization (ICH) regulations.
- Knowledge with basic computer systems such as Microsoft Office (Word, Excel, Power Point, and Outlook)
- Microbiology experience with testing sterility, endotoxin, and EM.
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.