*This is a second shift position (2:00pm-10:30pm) and is eligible for a shift differential on top of base salary*
Position Summary:
These roles are responsible for analytical testing and laboratory support in a contract manufacturing facility.
Position Responsibilities:
- Testing: In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction.
- Execution of method transfer, method qualification, and/or method validation testing performed under protocol.
- Solution preparation.
- Organizes and processes samples according to GxP standards.
- Independent analysis and collation of data to draw conclusions.
- Enter data into control charts and LIMS; perform trend analysis.
- Supports lab investigation and deviation reports.
- Supports implementation of Corrective and Preventive Actions.
- Authors or revises SOPs, protocols, or technical reports.
- Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data.
- Tracks department metrics upon request; actively engages in improvement of department metrics.
- Partakes in continuous improvement projects or leading simple improvement projects.
- Ensures state of safety and regulatory audit readiness at all times.
- Maintains work to current Good Manufacturing Practices (cGMP).
- Ensures Trainer qualification status to expand team matrix.
- Laboratory support - ensures areas are neat, clean, organized, and equipment is functioning.
- It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility.
Minimum Requirements:
- Senior QC Analyst requires Bachelor’s degree as described and 4+ years’ experience or Master’s Degree with 2+ years experience.
- Strong ELISA experience preferred.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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