KBI: US - Supervisor, QA

KBI Biopharma•Durham, NC

53d

About The Position

The MQA Supervisor/Senior Supervisor is responsible for leading the MQA batch record review team. Responsible for the review, approval and posting of manufacturing batch records, internal support records, and related client records. Supervisor level loads work across the group and coordinates the support for external client reviews and timely resolution of comments. They will collaborate directly with the MQA Floor Support and Manufacturing teams to complete timely reviews and support dispositions. They are to collaborate with Manufacturing on team initiatives and provides ongoing feedback in order to improve overall efficiency. The MQA Supervisors is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site. As part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to internal MQA team and customers with respect to batch record review process. The MQA Supervisor's team shares responsibility for the inspection readiness of the site.

Requirements

AS/AAS and 4+ years' experience (Supervisor), BS and 6+ years' experience (Senior Supervisor) in a QA or cGMP environment in Biopharmaceuticals or equivalent. Experience in QA Batch Record review and disposition and/or related Quality Systems, with 1-3 years of supervisory experience.
Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.
Strong understanding of FDA, EU, and ROW cGMP regulations.
Ability to read, analyze, and interpret English documents.
Ability to respond effectively to the most sensitive inquiries or complaints.
Ability to write technical correspondence that is easy to follow and understand.
Ability to make effective and persuasive presentations on controversial or complex topics to senior management peer group, employee groups, and customers.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Basic math skills are required.
Ability to apply concepts of basic algebra and statistics.
Use of hands and fingers to manipulate office equipment is required.
Position may require sitting or standing for long hours of time.
Support manufacturing and warehouse operations to include movement, gowning, and/or lifting
Proficient in Microsoft Excel, Microsoft Word, Outlook, PowerPoint, and Internet. Ability to use enterprise software, such as Document Management Systems, Learning Management Systems, Asset Management Systems, Electronic Lab Notebooks, Enterprise Resource Planning systems or similar programs.
Knowledge of and experience using a computer, telephone, copy machine, a printer, a scanner

Responsibilities

Performs and coordinates the compliance review of master batch records, executed batch records, and internal support records.
Maintains timely resolution of batch record comments for Manufacturing and Clients.
Responsible for coordination and tracking of all records from review to closure.
Documents and reports out metrics to relevant operational meetings as needed.
Collaborates with functional areas to improve cycle time for batch record review and subsequent disposition.
Attends relevant operational meetings in support of record disposition.
Develops and supports training program for QA review of batch records.
Provide oversight of training and certification to staff.
Supports department related Deviations and CAPAs
Supports Client Audits and Regulatory Inspections as area Subject Matter Expert.