oracle
Scientist, Microbiology
Solvias Group
USA
Full-time
Senior · 10+ years experience
Onsite
Discovered 2 weeks ago
gcp
Key Skills for This Role
gcp
Full Job Posting
Qualifications
- Essential Job Functions
- Ensure compliance with GMP regulatory requirements and SOPs.
- Process client samples, qualify controls/standards, document all processes in LIMS/ELN, review draft protocols, and other aspects of a laboratory operations regulated environment.
- Participate in investigations of processing deviations, non-conformity, OOS, change controls and other quality events as applicable.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
- Work collaboratively with cross-functional teams and customers.
- M.S. or Ph.D. in Microbiology or Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ years relevant experience.
- Experience working on rapid sterility, Bioburden, Endotoxin, and monocyte activation technologies in a GMP, GLP, or GCP environment.
- Experience in method development, qualification & validation of microbial methods.
- Excellent organizational skills, ability to work independently and collaboratively in a team environment.
- Strong written and verbal communication skills.
- Experience working with LIMS, automation, databases, statistics/programming, and building slide decks for client presentation.
- Lean 6Sigma.
- Able to multitask and adjust prioritization as necessary.
- Bioinformatics experience is desirable, but not a requirement.
- Experience working in a CRO/CDMO highly desired.
Requirements
- Other Desired Skills/Abilities
- Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
- NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Responsibilities
- Essential Job Functions
- Ensure compliance with GMP regulatory requirements and SOPs.
- Process client samples, qualify controls/standards, document all processes in LIMS/ELN, review draft protocols, and other aspects of a laboratory operations regulated environment.
- Participate in investigations of processing deviations, non-conformity, OOS, change controls and other quality events as applicable.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
- Work collaboratively with cross-functional teams and customers.
About Solvias Group
Pharmaceutical Manufacturing800 employeesFounded 1999
Privately held contract research organization providing cGMP analytical testing and manufacturing services to pharmaceutical and biotech companies.
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