J&J Family of Companies Analyst, Laboratory Quality Control (1 of 5) in San Angelo, Texas
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery.
The Analyst 1, Laboratory Quality Control will:
Execution complex analyses to raw materials and finish products (Solid Extraction, solvents, liquids, plastics, etc) to comply with current procedures and Pharmacopoeias. Responsible of reporting (documenting) and verify the laboratory data records including: standard logbooks, final results, reagents logbooks, etc; as per GMP’s regulations. Knowledge
Writing reports on chemical analyses and stating the technical findings.
Follow current compliance regulations and standards.
Report results using the following programs: Excel, Power Point, Empower and LIMS.
Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.
Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.
Performs other work related duties assigned by Team Coordinator and/or Facilitator.
Complies with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001, OSHAS18001)
Utilize the following laboratory instruments: UPLC, Karl fisher, GC, FTIR and pH.
A qualified candidate should meet the following criteria:
University / Bachelor Degree or Equivalent
Candidate must be able to work full time (40 hours per week) during the assignment.
1 Years of experience on a highly regulated Laboratory
Demonstrated knowledge and expertise in quality processes and regulatory requirements.
Knowledge on chemical principles, theories, practices and methodology in wet chemistry.
Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 & 21 CFR Part 4)
Experience with the following laboratory instruments: UPLC, Karl fisher, GC, FTIR and pH
This position is located in San Angelo, TX
United States-Texas-San Angelo
Ethicon Inc. (6045)