QA Specialist with Biotech experience

QA Specialist On the Floor

Baltimore, MD on site

Contract

Biotech exp is ++

The QA Specialist I professional will own and be responsible for the QA On the Floor program, QA work order review/approval program and expansion of CDMO operations at the site. This role involves the training and qualification of new QAPQ team members in BPR review and approval, LIMS, QA On the Floor, and Work order approval. The QA Specialist I will support the APR for ACAM2000 and JE-CV and the RA BLA Annual Report programs at the Emergent Canton, MA site. The Specialist I is a quality SME in LIMS for Product and Raw Material disposition process. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required. Specialist I will back-up the Specialist II in support to the ARC, and EBSI ACAM2000 meetings. The Specialist I has a dual role of performing the QAPQ daily work and being a leader in the group, who can make independent decisions as it relates to the work and projects.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
• Disposition of Product and Raw Materials & components. Quality SME in LIMS and SAP Master Data
• Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
• Provide data for functional area metrics for APR and RA BLA Annual Report
• Drive Continuous Improvement within QAPQ; Identify and improve system compliance and/or process challenges
• SOP generation, review, and approval
• Train QA team members in Batch Record review, QA On the Floor program, Work Orders, LIMS, Document generation and Raw Material and Product disposition
• Own quality records (Deviation/CAPA/Change Control).
• Must be capable to work independently and strategically to ensure day to-day activities are carried out in support of the business goals
• Interacts with leadership, direct manager, peers, internal customers, external clients, and other cross functional peers across Emergent to gain alignment on sound quality decisions.
• Lead and support additional work as required.
• Provide support during regulatory and internal inspection activities.
  
  

Thanks

Krish T

Krish@itminds.net