QA Specialist II-Manufacturing Oversight - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
Perform Quality Assurance review and approval of Deviation Reports.
Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
Review and release of Plasma pools to manufacturing.
Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
Review and release of raw materials in LIMS/SAP.
Perform audits of Nitrogen receipt process.
Perform notification and disposition of associated Lookback units.
Assist with quarantining and release of critical systems, equipment, and controlled environments.\
Write, review, and revise QA SOPs.
Review SOPs and documents from other departments and provide feedback as necessary.
Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
Assist with training of new employees.
Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12 hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift. Assist in other oversight activities, as needed
Coordinate and perform any additional activities or projects assigned by QA Management.
Experience with LIMS and SAP preferred.
Make sure candidates are aware they are working rotating schedule. If in production and there is holiday, you maybe scheduled to work that day. Not clocking in but need to be here for the hours 7am-7pm or 7pm - 7am. The spend most of time in manufacturing area all gowned up.
Variation to 4 QAs schedule, they work 1 week a month, so they follow the 12-hour shift kind of but not always. They plan schedule at start of quarter, so you know what's coming. (this also gives holidays in advance)
Look for someone who has experience, QA assurance experience is back (biopharma is best), QA food science industry good, manufacturing experience is ok too
QA oversight experience is most relevant
Other QA roles that might be helpful - doc control experience not enough experience alone
QC experience is good too (compliance experience) good
Manufacturing experience is ok but doesn’t always translate to success
Very wordy when talking about quality, if can explain it they typically understand it.
Independent team (not micromanaged) but everyone is visible to others, team player, seems to want to busy all the time
EDUCATION REQUIREMENTS:
Bachelor's Degree preferred but can be offset by experience.
EXPERIENCE REQUIREMENTS:
3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.