QC Lab Technician

Job Description

Job Description

Description :

Reporting to the QC Manager, the Analytical QC Technician I support's the accurate and timely testing and inspection of current products lines in their area of responsibility following customer requirements and / or established procedures.

Works with all areas of Operations and R&D in order 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 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 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.

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

Complexity of Tasks : Basic to complex

Independent Judgment : Minimal latitude for independent judgment

Extent of Supervision : Works under moderate supervision

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.

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.

A good fundamental understanding of their assigned tests and be able to ascertain the validity of test results.

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.

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)

SHE & 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.

Encourages colleagues and management to improve SHE results and prevent incidents.

It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.

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 their SHE 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).

Authorities : Acceptance and Rejection of raw materials, components, and finished product 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 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.

Qualifications :

High School Diploma and or GED or associate degree

Associates degree in the biological or chemical sciences.

Years of experience may be substituted for degree.

Quality Inspection, GMP GDP 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.

Good interpersonal skills and must function well in a team environment.

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.