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Job Description
OBJECTIVES:
Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
Focused primarily on providing entry level support and guidance on basic and routine quality-related issues.
ACCOUNTABILITIES:
Performs documentation review thoroughly, with a high attention to detail.
Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
Analyzes and interprets projects, studies, or investigations to determine next steps under guidance of Team Lead or higher.
Identifies technical issues and define resolution, under direction of Team Lead or higher.
Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
Revises department-specific controlled documents under direction of a Supervisor.
Receives general daily supervision on routine work and detailed instruction on new assignments.
Identifies and proposes Quality Process and system improvements.
Complete mandatory training within required timeframe
Performs additional duties, as assigned, including support of Compliance and Supplier Quality functions.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 1-2 years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
Basic knowledge of quality and/or GMP principles.
Familiarity or experience with the following is preferred: Auditing; basic statistics; Internal / External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations
Ability to handle multiple tasks concurrently and in a timely fashion.
Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
Must be able to read, write and converse in English.
Must display eagerness to learn and continuously improve.
Positive work attitude that supports teamwork and continuous improvement.
Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
LICENSES/CERTIFICATIONS:
Certified Quality Auditor (CQA) a plus
PHYSICAL DEMANDS:
Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
Wrist and hand motion (e.g. typing, writing)
OTHER REQUIREMENTS:
May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
Willingness to travel to various meetings or training, this could include overnight trips.
