QC Specialist I

仕事内容

Key Responsibilities (include but are not limited to):

• Serve as SME on assigned QC Lab Support processes including LIMS.
• Receive incoming samples, verify documentation, and log sample information into LIMS.
• Execute processes to support sample receipt and processing or aliquoting for release/stability testing and retains.
• Label, store, and organize samples according to established procedures and storage requirements.
• Coordinate sample transfers to internal and external testing labs.
• Perform routine cleaning, maintenance, and restocking of sample storage areas.
• Collaborate with MM, QA, and other QC functions—including Corporate QC—to support requirements around Raw Material sampling, testing, and disposition.
• Manage and complete all shipping activities within QC functions.
• Complete routine review of records, such as sample chain of custody forms, processing logs, logbooks, and other documentation generated within QC Lab Support.
• Conduct training on assigned QC processes.
• Author controlled documents such as SOPs, forms, etc., as needed.
• Assist with deviation, investigation, CAPA and change control activities as needed.
• Provide updates during daily and weekly meetings.
• Participate in Lean Lab and other Operational Excellence initiatives.
• Comply with all safety, quality, and regulatory guidelines.
• Perform other duties as assigned.

Basic Qualifications:

• Bachelor’s Degree and at least 2 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• Associate Degree and at least 4 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• High School Degree and at least 5 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory.

Preferred Qualifications:

• Thorough knowledge in applying GMP in QC lab.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects
• Proficient in Microsoft Office, Excel, Visio, and other related applications
• Ability to effectively negotiate and develop collaboration within teams and amongst team members.
• Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
• Comfortable in a fast-paces small company environment with minimal direction and able to adjust workload based on changing priorities.

Shift:

Sunday to Wednesday morning shift 3p-2a (NIGHT SHIFT)