Analyst III, QC Laboratory Services-3rd Shift

Bora Pharmaceuticals•Baltimore, MD

10d•$88,000 - $115,000•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This role will be responsible for performing analytical testing per cGMP in support of Bora raw material, in-process, final product, stability, and method transfer testing. This position will support our 3rd-shift Operations, working 10pm-6:30am, Monday - Friday. Eligible for shift differential.

Requirements

B.S. in Chemistry, Biochemistry or other Technical Science field required with minimum of 3-5 years in a cGMP laboratory required or master's degree with 2 years of laboratory experience required.
Demonstrated knowledge of wet chemistry, titration, UV and chromatography.
GLP/GMP experience required.
HPLC/GC/IC Chromatography experience is required.
Knowledge of new and existing testing applications.

Responsibilities

Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.
Execute complex methods requiring difficult sample preparation or data analysis.
Assist with the design of method validations and execute validation studies, including method transfer activities.
Work with Project Managers and QA to ensure timely testing and release of samples.
Perform instrumental analysis such as Karl Fischer, UV, HPLC, and Gas Chromatography.
Inform supervisor upon observing out-of-specification (OOS) results.
Participate in investigations of OOS results and other related studies.
Participate in calibration and troubleshooting of various types of equipment, including proactive resolution of instrument issues.
Write protocols and reports as necessary.
Plan and execute experimental tasks and obtain and interpret experimental data with minimal guidance.
Perform review of calculations, logbooks, and other data to execute LIMS approval, lot release protocols, and final product data authorizations or approvals.
Write and review SOPs and Testing Standards as necessary.
Interact with clients as necessary regarding cGMP, tech transfer methods, or stability issues.
Assist in training other Analysts.
Review, analyze, interpret, and report data.
Verify and enter approved results in LIMS.
Practice good documentation and laboratory safety procedures per Standard Operating Procedures.
Support department compliance and productivity goals.
Track time worked per project.
Training and education may be conducted using virtual reality/artificial intelligence.
Participate in meetings as required.