Website eTeam Inc.
eTeam Inc.
Company : eTeam Inc.
Job Title – Quality Control Analyst II
Job Location – Fort Worth, TX
Duration – 12 months
We are seeking a highly skilled and detail-oriented Laboratory Instrument Technician to support the calibration, qualification, and performance maintenance of laboratory equipment. This role is essential for ensuring data integrity, regulatory compliance, and operational efficiency across our lab systems.
Key Responsibilities
- Perform routine and scheduled calibrations of laboratory instruments (e.g., HPLC, balances, spectrophotometers).
- Execute preventive maintenance and performance checks in accordance with SOPs and manufacturer specifications.
- Lead and support instrument qualification activities (IQ/OQ/PQ) for new and existing equipment.
- Collaborate with QA and IT teams to implement and maintain Computer System Validation (CSV) and Computer Software Assurance (CSA) protocols.
- Troubleshoot equipment issues and coordinate repairs or service with vendors.
- Maintain accurate records of calibration, qualification, and validation activities in compliance with regulatory standards (e.g., GMP, GLP, ISO 17025).
- Assist in audits and inspections by providing documentation and technical support.
Qualifications
- Minimum 2–3 years of experience in laboratory instrument calibration and maintenance.
- Hands-on experience with instrument qualification protocols (IQ/OQ/PQ).
- Working knowledge of CSV and CSA frameworks in regulated environments.
- Familiarity with quality systems and regulatory requirements (FDA, EMA, ISO).
- Strong documentation and organizational skills.
Preferred Skills
- Experience with calibration management software and electronic documentation systems.
- Understanding of data integrity principles and risk-based validation approaches.
- Certification in instrumentation, metrology, or validation (e.g., ASQ CCT, GAMP) is a plus.
Other Responsibilities
- Ensure that lab cleanliness and safety standards are maintained.
- Develop and qualify new testing methods.
- Train other analysts to perform laboratory procedures and assays.
- Perform visual inspections of finished products.
- Participate in internal assessments and audits as required.
- Identify and troubleshoot equipment problems.
- Evaluate new technologies and methods to make recommendations regarding their use.
- Serve as a technical liaison between quality control and other departments, vendors, or contractors.
- Coordinate testing with contract laboratories and vendors.
- Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
- Write or revise standard quality control operating procedures.
- Supply quality control data necessary for regulatory submissions.
- Receive and inspect raw materials.
- Review data from contract laboratories to ensure accuracy and regulatory compliance.
- Prepare or review required method transfer documentation including technical transfer protocols or reports.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Participate in out-of-specification and failure investigations and recommend corrective actions.
- Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
- Investigate or report questionable test results.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Identify quality problems and recommend solutions.
- Evaluate analytical methods and procedures to determine how they might be improved.
- Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
- Calibrate, validate, or maintain laboratory equipment.
- Compile laboratory test data and perform appropriate analyses.
- Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.