Supports the accurate and timely testing and inspection of current product lines in their area of responsibility following customer requirements and/or established procedures.
Works with all areas of Operations and R&D to ensure that products are of consistent and high quality by conducting standard and non-routine laboratory tests, performing product inspections, and organizing data in a manner compliant with GMPs.
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 the 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 the 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.
To produce accurate results, without assistance, but is not expected to analyze, diagnose or troubleshoot non-routine or unexpected results or instrumentation issues.
Authorities: Acceptance and Rejection of raw materials, components, and finished products per written specifications and drawings.
Assist process engineering and manufacturing of new products by providing inspection data for these R&D projects in order to gage the 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.
Encourages colleagues and management to improve SHE results and prevent incidents.
Complies with all job-related safety, security and other training requirements.
Assist in insuring that SHE regulations are in place and followed upon by making SHE a regular subject of discussion in team meetings and holding employees accountable for behavior/attitude.
Supports and enforces the policy of reporting incidents, possible SHE incidents and improvement possibilities and checks that the work is routinely assessed.
Assists in insuring that Security regulations and facilities are in place and followed upon and correctly used by monitoring this and making a Security a regular subject of discussion in team meetings and holding employees accountable for their Security behavior/attitude.
Assists and supports management in ensuring employees know what they are required to know and can do, to perform their job in a (SHE) responsible way
Supports management in ensuring that all procedures and instructions for the job are workable with safety analysis and followed by routine observation and auditing employees under his/her supervision.
Conducts periodical and non-periodical inspection.
Facilitates and implements continuous work method improvement.
Formulates standard operational procedure (SOP).
Comply with Life Saving Rules
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.
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.
SHE and Security- Acts in such a way that the organization will learn from its incidents.
Incidents will be investigated, possible improvements (and incidents) are reported, and the risks of the work are assessed regularly/routinely.
Encompasses all QC Inspector responsibilities but within the context of a laboratory that is responsible for analytical and mechanical testing of biomaterials-based products.
Tests in the laboratory cover a wide scope of scientific fields supporting multiple product lines (lists not exhaustive):
Associates or Bachelor's degree in the biological or chemical sciences.
Years of experience may be substituted for degree.
A basic competency with regards to the analysis performed in the laboratory.
Good interpersonal skills and must function well in a team environment.
Expected to present themselves with professionalism.
Independent Judgment: Minimal latitude for independent judgment
Good fundamental understanding of their assigned tests and be able to ascertain the validity of test results.
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 of sampling techniques (ANSI/ASQC Z1.4-2003)
Must have excellent writing, editing and proofing skills
Proficient using MS Word, Excel and Outlook
Can adhere to Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards.
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.