- RPM Research (Solana Beach, CA)
- Director, GLP Quality Assurance & Compliance Building a Culture of Quality & Compliance in a Leading In Vivo Research Facility Company Overview We are a pioneering ... , we are seeking an experienced Director, GLP Quality Assurance & Compliance to establish and lead a Quality...up to full compliance. Reporting to the Test Faciliyt Manager , this leader will develop policies, oversee audits,… more
- IntePros (Philadelphia, PA)
- …sterilization equipment and processes. This includes bioburden environmental monitoring and sterility assurance strategy. The position is also responsible for ... IntePros is currently looking for a Sterilization Manager (Validation) to join one of our growing...product requirements and applicable industry standards. Ensures that any sterility assurance strategy provides appropriate risk-mitigation in… more
- Veterans Health Administration (Baltimore, MD)
- …He/she will notify the chief of SPS of any discrepancies. Performs quality assurance inspections on sterilized RMW prior to issue, such as dryness, expiration date, ... pass pre-employment physical examination. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …industry with GMP/GLP knowledge a plus but not required. Direct experience in sterility assurance or products sterilization required. Must have experience in ... TX, the Regional Validation Engineer will report to the facility General Manager . Additionally, they will be a technical representative for the Sterigenics' Director… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Program Manager , DS business unit - Sterility Assurance is responsible for technical management and performance of the ... sterility assurance program for the...sterility assurance program for the DS business unit...across the network. and mitigation of quality risks. The Program Manager is a key advisor for… more
- Lilly (Indianapolis, IN)
- …inspection readiness and ensure timely closure of all regulatory commitments related to sterility assurance program execution. + Provide support during ... products, and scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Sr. Manager of TS/MS Sterility Assurance is responsible for… more
- Danaher Corporation (Duncan, SC)
- …Carolina and will be an on-site role. What you will do: + Responsible for the sterility assurance program at site level. This includes dose audit program ... management. This position reports to the Sr. QA Manager Contamination Control and Sterility Assurance...value to our lives. Whether it's a health care program or paid time off, our programs contribute to… more
- ThermoFisher Scientific (Greenville, NC)
- …more information, please visit www.thermofisher.com . **_Position Summary_** Accountable for Sterility Assurance across site and will own/promote/define the ... systems listed as key responsibilities. Lead the Sterility Assurance department. **_Key Responsibilities:_** + Contamination Control Strategy… more
- ThermoFisher Scientific (Greenville, NC)
- …oral solid dose drug products from development to commercialization. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility ... assigned areas) + Define, oversee, and improve the EM program + Oversee the Media Fill Program ...future expectations + Lead sophisticated investigations into issues impacting Sterility Assurance (ie Adverse EM trends, media… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Aseptic Sterility Assurance Manager Department: Production Location: Monroe, NC START YOUR APPLICATION ... direction of the Senior Director of Operations, the Aseptic Sterility Assurance Manager is responsible...This position will have ownership of the media fill program including generation of the media fill protocol, scheduling,… more
- Integra LifeSciences (Mansfield, MA)
- …changes. + Provides guidance and input on the resolution of sterility related non-conformances + Supports sterilization validations, cleaning validations, and ... and compliance always. + Participate in audits and other compliance program -related activities. + Executes other duties/responsibilities as assigned by manager… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Manager , QA for QC is responsible for quality oversight of the Quality Control ... procedures and global current Good Manufacturing Practice (cGMP). The Senior Manager provides Quality support and oversight for QC laboratory operations such… more
- Integra LifeSciences (Princeton, NJ)
- …the accuracy and sustainability of supplier requirements as they pertain to sterility assurance and drive cross-functional collaboration with supplier quality ... + Review, assess, and update supplier requirements as they pertain to sterility assurance and microbiological endpoints. + Collaborate in the development… more
- Medtronic (Juncos, PR)
- …Products Quality Assurance , and a Metallurgy Laboratory and indirectly for Microbiology/ Sterility Assurance and Supplier Quality. The role will also support ... mission globally. + May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …this individual will help support the microbial contamination control and sterility assurance activities for the radiopharmaceuticals produced at the ... testing for microbial test method development, qualification and validation for bioburden, sterility , and endotoxin testing + Support review and approval of sample… more
- Boehringer Ingelheim (Athens, GA)
- …years related experience and/or training in a Manufacturing environment in Quality Assurance , Quality Control, Sterility Assurance , Engineering, Production, ... licensed biopharmaceutical or biological products. + Experience with aspects of sterility assurance (ie, environmental monitoring, aseptic process simulations or… more
- Akina Pharmacy (Sterling, VA)
- …medications, complete rigorous cleaning and sanitization protocols, and conduct quality assurance tasks to ensure patient safety and product efficacy. You will ... and inventory checks (20-30 per week) + Complete ongoing self-guided trainings, and manager -led competencies and evaluations (12-15 per year) If you want to come to… more
- Food and Drug Administration (College Park, MD)
- …maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls. NOTE: Applicants ... regulatory task forces, and agency-wide initiatives focused on enhancing program effectiveness, developing enforcement policies, and improving national compliance… more
- Lilly (Pleasant Prairie, WI)
- …others in the areas of safety, quality, operational execution, sterility assurance , and continuous improvement. The Manager is also responsible for leading ... contact for other areas such as Production Planning, HR, Quality Assurance , Engineering and Environmental/Safety issues. + Present operations investigations and… more
- Charles River Laboratories (Dixon, CA)
- …transfer, pseudopregnant and stud male colony management, stud male vasectomies and sterility testing, and other support tasks for the ART (Animal Reproductive ... review of data processes and reports to the lab manager . + Review, comprehend and comply with all SOPs,...comprehend and comply with all SOPs, guidelines/policies, and quality assurance standards pertaining to assigned responsibilities, and to the… more
