Responsibilities:
Primarily responsible to provide QA oversight for the qualification of Equipment, Facilities, Utilities, Analytical Instruments and Computerized Systems, including:
· Supporting qualification and startup activities for large capital project as a Quality Assurance resource,
· Provide QA review and approval of system lifecycle documentation (Requirements Specifications, Configuration Specification, Risk Assessments, IQ/OQ/PQ Protocols, Summary Reports) for equipment, facilities, utilities, computerized systems and analytical instruments,
· Perform QA review and approval of validation non-conformances,
· Assist in the resolution of compliance issues in partnership with process owners and SMEs.
· Provide QA support for any other project related activities as necessary.
Experience:
· Bachelor’s Degree in Engineering or Life Sciences,
· Minimum of 7 years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing environment (FDA, EMA, MHRA),
o Some experience in biologics and/or gene therapy manufacturing facilities,
· Must have experience providing QA oversight of qualification of equipment, utilities, facilities, and analytical instrumentation and computerized systems,
· Experience with large capital project and facility startup is desirable,
· Experience with QC analytical systems is desirable,
· Must be knowledgeable of current industry practices and regulatory expectations regarding qualification and validation, as well as data integrity requirements for computerized systems,
· Must have ability to communicate effectively with a wide range of personnel and cross-functional teams,
· Must have capability and desire to perform detailed review of GMP documents,
· Experience working with eVLMS, eDMS and CMMS
Compensation:
$50-70/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
