Quality Control Specialist I - $8,000-Sign On

Job Description

We are seeking a highly motivated individual to join us as a QC Specialist 1, Quality Control Lab Support, reporting to the Manager, Quality Control Lab Support in Frederick, MD. In this role, you will execute tasks associated with Sample Management, Raw Material Release, Shipping, System Administration and other Lab Support QC functions, and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.

This group will operate 7 days a week, with an extended, overlapping shift structure. 

Additional Responsibilities (include but are not limited to):

• Serve as SME on assigned QC Lab Support processes including LIMS.
• Execute processes to support sample receipt and processing or aliquoting for release / stability samples for testing and retains.
• Work with MM, QA and other QC functions including Corporate QC to implement and support requirements around Raw Material sampling, testing and disposition.
• Manage and complete all shipping activities within all QC functions.
• Perform System Administration functions for QC Equipment.
• Complete routine record review of records, e.g., of sample chain of custody, processing, 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.
• Author deviations, investigations, CAPAs and change controls as needed.
• Complete required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
• Provide updates at daily and weekly meetings.
• Participate in Lean Lab and other Operational Excellence initiatives in the group.
• Additional duties as assigned.

Basic Qualifications:

• Master’s Degree OR
• Bachelor’s Degree and 2+ years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory or a Master's degree in Biotechnology, Biological Sciences or related discipline
• Associate Degree and 4+ years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory or a Master's degree in Biotechnology, Biological Sciences or related discipline
• High School Degree and 5+ years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory or a Master's degree in Biotechnology, Biological Sciences or related discipline

Preferred Qualifications:

• Strong 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 build collaboration within teams and amongst individuals.
• 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.

Does this sound like you? If so, apply today!

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue.  Applies to external hires only.

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