QC Lab Technician I

Job Title: QC Lab Technician I

Location: Exton, PA

Hours/Schedule: M-F (7AM-3:30 PM)

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

• Conduct laboratory tests and inspections on raw materials, in-process, and finished products.
• Analyze and maintain all test data according to cGMPs.
• Conduct thorough batch record reviews as part of material approval process.
• Initiate NCRs as needed and execute the final disposition, including MRB transactions.
• Organize laboratory supplies and documentation.
• Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.
• Perform routine equipment maintenance and calibration on equipment.
• Conduct routine environmental monitoring on controlled areas and water systems.
• Offer suggestions on improvement of methods and implement through change control process.
• Perform other duties as assigned.
• Adhere to company Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards.

Requirements

• Associates degree in the biological or chemical sciences. Years of experience may be substituted for degree.

• Minimum 0-3 years of experience demonstrating progressive inspection and testing responsibilities in a laboratory setting
• Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment
• Knowledge of commonly used concepts, practices, and procedures within a QC environment
• Basic knowledge & understanding of sampling techniques (ANSI/ASQC Z1.4-2003)
• Must have excellent writing, editing and proofing skills
• Proficient using MS Word, Excel and Outlook

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.