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USA - NC - Durham - Hamlin Rd, United States of America
Onsite
This position operates on a night shift 2-2-3 schedule and is eligible for a 15% shift premium.
JOB SUMMARY
Oversee the Quality Support (Shop Floor QA) function at KBI Biopharma supporting the manufacture of biopharmaceuticals, providing QA support on the manufacturing floor. Lead the QA-on-the-floor inspection program, review of master and executed batch records, logbooks, room changeovers and room releases. Provide client project support to resolve issues related to GMP manufacturing as needed. Level load work across team in support of batch release dates, daily manufacturing release schedules, and project priorities. Coaches and mentors’ staff.
JOB RESPONSIBILITIES
Supervise the Quality Support group supporting GMP manufacturing of bulk drug substance (Biologics).
Manage QA oversight of on-going GMP manufacturing activities. Performs QA-on-the-floor inspections. Provides compliance support to manufacturing operators during processing on the floor.
Performs QA batch record review of Master and Executed batch records.
Provide client project support to resolve issues related to GMP manufacturing as needed.
Works directly with Manufacturing Operations to resolve deviations and other compliance issues in a timely manner.
Support Deviations, CAPAs and Change Controls for Manufacturing Operations. Support Document Control for issuance of batch records as needed during off hours.
Supervises direct reports providing coaching and mentoring.
Attend relevant operational meetings in support of disposition activities. Support Client Audits and Regulatory Inspections as required.
MINIMUM REQUIREMENTS
Knowledge, Skills, Abilities
BS and 6+ year experience or MS and 4+ years’ experience in a Quality engineering, Quality on the Floor, or technical services/manufacturing sciences role or Equivalent. 0 - 2 years of Supervisory experience preferred. Proficient in Project Management and Quality Systems. Strong understanding of technical and compliance requirements for clinical and commercial Biopharmaceutical programs, and FDA, EU, and ROW cGMP regulations.
Language Ability
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Reasoning Ability
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.
Math Ability
Basic math skills are required. Ability to apply concepts of basic algebra and statistics.
Physical Demands
Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables.
Computer Skills
Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management
Equipment Use
Computer, telephone
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
