Posted in Information Technology 30+ days ago.
Location: Van Nuys, California
LOCATION: Van Nuys, Ca
The Quality Assurance Supervisor is responsible for executing and supervising daily operations and quality activities and objectives in Receiving & Inspection (QARI), which include providing daily quality oversight and supervision to ensure raw materials and in-process materials are in compliance with chemical, biological, microbiological, and/or physical quality control programs and external regulations, as well as documentation review for accuracy and compliance to procedure, walkthroughs to assure cGMP compliance, participate in troubleshooting and problem solving for manufacturing issues related to raw materials, in accordance with FDA and regulatory standards, ISO requirements and internal standard operating procedures.
Assure compliance with cGMP, GDDP, and company procedures. Support internal and external audits.
Identify and assess quality and compliance risks in activities and processes according to regulatory agency requirements, Takeda Quality Standards, and practices.
Provide assessments to support good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements.
Uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Supervise ongoing daily departmental activities for Quality Assurance Receiving & Inspection, including supervision of personnel
Plan and schedule the work of Quality Analysts and Quality Inspectors to ensure timely release of raw materials
Work closely with Manufacturing, Quality, Validation, Quality Control, and Engineering to ensure adequacy and appropriateness of inspection parameters, part specifications, and test methods for raw materials
Participate in regular meetings with Planning, Purchasing, Warehouse, Manufacturing, and customers as needed to ensure clear communication and goal alignment
Partner with Manufacturing, Quality Control, Engineering, Supply Chain and Warehouse to ensure sound quality decisions are made with compliance to standards and procedures
Perform or oversee Raw Material Release Review, Deviation Lifecycle Management (i.e. Deviation, CAPA, Lab Investigation review/approval), Change Control, Gemba, and provide quality representation in meetings such as, but not limited to QWTs, tiered meetings, and other project related initiatives
Provide leadership, guidance, training and coaching for QA’s and Inspectors to support department goals
Participate in quality assessments of internal operations and suppliers to analyze compliance and assess risk
Identify and participate in continuous improvement and digital projects with the objective of achieving higher quality, reliability, and cost improvement
Hire, train and evaluate personnel. Perform mid- and yearly performance review of all direct reports and make wage and salary recommendations
Perform audit support/preparedness efforts and promote site understanding of regulatory requirements.
Be directly involved in and where appropriate lead initiatives and project linked to key plant metrics or quality goals
Embraces Takeda safety culture and initiatives
Ensure adherence to the department’s budget
Assist Quality Manager on an as needed basis
Must be willing to work flexible hours and rotations, if necessary
May perform other duties as assigned
Have knowledge of biopharmaceutical/biotechnology manufacturing theories and processes
Result driven with ideas to drive continuous improvement and process simplification with breakthrough solutions
Be able to have great attention to details is necessary.
Strong analytical and problem-solving skills/critical thinking and problem-solving skills
Good verbal and written communication skills
Ability to operate in a dynamic, high-paced, cross-functional environment.
Strong interpersonal / communication / influencing / negotiation skills
Good project management skills
Proficient with Microsoft Word, Excel, PowerPoint
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of Pharmacopeia (USP, EP, etc.)
Must be able to effectively manage employees, conduct performance reviews, establish development plans, and manage resources
Proficient knowledge of laboratory and inspection tools, and warehouse equipment, as well as chemical handling
Be able to review and approve investigations, as assigned
Be able to support departmental / plant goals
EDUCATION AND/OR EXPERIENCE:
Typically requires a bachelor’s degree – science, engineering, or other related technical field preferred, with at least five (5) years of related work experience in quality with a pharmaceutical company or other similarly regulated industry preferred.
Must be able to lift, push, pull and carry up to 10 lbs.
In general, the position requires a combination of sedentary work and standing or walking around observing conditions in the facility
Will work in office and warehouse environment
Must be able to work in controlled environments requiring special gowning
Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment
Must be able to work in a cold environment
Will work with or around moving equipment and machinery
May be exposed to dust, gases, and fumes
May be working in a loud area that requires hearing protection and/or other protective equipment to be worn
OTHER JOB REQUIREMENTS:
Must be able to work multiple shifts, including weekends
Must be able to work overtime as required
May be required to travel for business reasons, e.g. training and meetings. 15% travel
This post excludes CO applicants
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.