Validation Specialist III Job Summary
- QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets the intended use. This position is responsible for qualifying computerized instrument associated software used for analytical and microbiological testing at the Allston Landing Facility.
Education & Qualifications
- Execution and coordination of activities to qualify software
- Writing protocols, reports and procedures, coordinating the purchase, commissioning and introduction to the QC laboratory.
- Establish and maintain Equipment History Files (EHF).
- Coordinate all services provided by vendors, ensuring vendors meet all site requirements.
- Schedule/plan/execute validation activities.
- Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience or Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience
- Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA.
- "Demonstrated scientific technical writing ability.
- Knowledge of USP 1058 and GAMP methodology.
- Knowledge of 21CFR Parts 11, 210, 211, 600 and 610 and Annex 11
- Previous hands on experience performing software validation compliant with 21CFR Part 11 and Annex 11.
- Proficient in Outlook, Microsoft Word, and analytical instrumentatin software, e.g. SoftMax Pro.
- Ability to gown and enter laboratory
- May require off shift work to support activities
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.