Quality Control Laboratory Technician

The Analytical QC Laboratory Technician I is expected to have a basic competency with regards to the analysis performed in the laboratory. When trained, the Technician I is expected to produce accurate results, without assistance, but is not expected to analyze, diagnose or troubleshoot non-routine or unexpected results or instrumentation issues.

The Technician I is expected to have good interpersonal skills and must function well in a team environment. The technician I is not expected to be a leader within the laboratory but is expected to present themselves with professionalism.

Project Management or Special Assignments:

• Assist process engineering and manufacturing of new products by providing inspection data for these R&D projects in order to gage capability of process to manufacture parts desired by a customer.
• Support process improvement initiatives in accordance with Biomedical Continuous Improvement Program.
• Aid in the development and validation of new analytical methods, and qualification and maintenance of new test equipment.

Key Areas of Accountability / Responsibility:

• 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 Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards.

Complexity of the Job

• Will work primarily in QC laboratories and manufacturing clean rooms.
• Must follow all safety regulations including the wearing of appropriate attire (lab coat, gloves, goggles, mask, respirator etc.).
• May be required to work with toxic and/or caustic chemicals, or other hazardous materials.
• QC Laboratory function at Biomedical Exton encompasses all QC Inspector responsibilities but within the context of a laboratory that is responsible for analytical and mechanical testing of biomaterials based products.
• The laboratory function requires versatile and competent personnel who can shift among a varied set of functions and tests, and learn scientific principles as new products and test methods are developed and transferred to QC.
• Tests in the laboratory cover a wide scope of scientific fields supporting multiple product lines (lists not exhaustive):
• Microbiology (e.g. Endotoxin, Bioburden, Environmental Monitoring)
• Wet Chemistry (e.g. Titrations, Moisture Testing, UV-VIS assays, Kjelhdahl Nitrogen, Hexanes, IV)
• Spectral & Dry Chemistry (e.g. FTIR, XRD, PSD, Porosity, DSC, Ash Content, Solids)
• Analytical Chemistry / Chromatography (e.g. GC, SEC, HPLC)
• Bioanalytical (e.g. DNA Quantification, Micro-BCA, Blyscan)
• Mechanical Testing (e.g. Suture pulls, Wet Tear, Compression, Injection)
• The level technician should have good fundamental understanding of their assigned tests and be able to ascertain the validity of test results.
• The position also requires supporting the development work required for updating test methods for reasons such as automation to increase efficiency, instrument changeout due to end-of-life, software upgrades, or implementing alternate methods.

Knowledge and Educational Level

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

Required Level of Experience

• 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