Top 3 Must Have Skill Sets:
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical concept to the team and senior management staff.
Demonstrate Proficiency at writing and reading procedures.
Demonstrated Proficiency using Excel, word and power point.
7 pm- 7 am
Requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to its operations, or its staff.”
The Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and engineering staff during the on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations.
In addition the PQA position personnel will support activities for facilities such as utilities, equipment, and systems. Review quality documents related to SOPs (standard operating procedures), user requirements, risk assessments, engineering, automation, commissioning, facility, utility, environmental qualification and validation. Support execution of, and change management related to, site acceptance, commissioning tests, facility qualifications and validation activities; Execute daily operations per management guidance in a dynamic environment; Perform OTF (on-the-floor) quality review of documents, such as equipment logs, training records, testing results, batch records and supporting documents; Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards; Provide guidance during on-the-floor analytical testing; Support audits, inspections and investigations, as needed.
Basic qualifications: Bachelor degree in any scientific field or 3- 5+ YOE
"This posting is for Contingent Worker, not an FTE"