Job Snapshot
Location:
Las Vegas, NV 89101
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Job Type:
QA - Quality Control
Biotech
Health Care
Experience:
At least 1 year(s)
Contact Information
Description
Octapharma Plasma Inc. is a international company dedicated to improving the health and lives of patients worldwide by providing superior products and constant innovations. We are currently looking for a qualified Quality Assurance Supervisor.
JOB SUMMARY:
Serving as a member of the Center Management Team,the Quality Assurance Supervisor is responsible for the overall quality program of the Donor Center (donors, products, samples, staff, etc.). Provides advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality. Oversee the Quality Assurance Technicians daily work assignments and ensure proper training is obtained. The QAS has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion.
ESSENTIAL JOB FUNCTIONS:
· Determines if quality activities and manufacturing records are in compliance with SOPs and regulatory requirements, determines the need for corrective actions, ensures proper documentation, and determines effectiveness of the action..
Advises other management team members and staff regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality, and resolution of same; develops and implements corrective actions.
· Performs final QA review and release for all product shipments and associated documents, to ensure shipment meets customer specifications.
· Performs regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing, storage and shipping.
· Conducts regularly scheduled staff meetings with respective Quality staff.
· Participates in the interviewing and hiring of Quality Assurance Technician, and back-up Quality Assurance Technician.
· Determines and prepares work schedules of the Quality staff to ensure adequate center coverage.
· Provides direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames.
· Identifies desired career path goals of the Quality staff and provides coaching and mentoring to aid the Quality staff in achievement of career goals.
· Writes and presents performance reviews to Quality staff. Delivers corrective/disciplinary action and termination when Quality staff performance is inadequate.
· Prepares staff and co-hosts both internal and external audits. Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames.
· Ensures that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff.
· Obtains certification as a Quality Trainer. Will be responsible for training of center Quality Assurance staff.
Provides support and assists other members of the Center Management Team in efforts to meet the center and company goals.
Analyzes tracking and trending data, determine appropriate actions to improve trending.
Requirements
· Bachelor's degree in applicable field of study preferred. Equivalent combination of education and job experience may be considered.
· ASQ certification preferred.
· Supervisory experience preferred.
· Must have a minimum of one (1) year work experience in the biologics industry, preferably in a donor center, and a minimum of one (1) year work quality assurance related experience.
· Must have legible handwriting.
· Must possess knowledge and aptitude to learn various computer software; such as word processing, spreadsheets, or other related software programs.
· Must have adequate communication skills and be able to effectively communicate with people of all levels.
· Must have excellent organizational skills and must be detail-oriented.
· Ability to interpret SOP’s and regulatory requirements.
· Ability to make decisions impacting the product and donor safety based on independent judgment and discretion.
PHYSICAL REQUIREMENTS:
· Ability to sit or stand for extended periods for up to four (4) hours at a time.
· Ability to tug, lift, and pull up to thirty five pounds.
· Occupational exposure to blood borne pathogens.
· Ability to read and review documents for up to four (4) hours at a time.
· The employee is required to enter an environment with a temperature of -30°C or colder.
· Exposure to various odors and chemicals; human source products and various chemicals.
Benefits: We offer competitive compensation and benefits including medical, dental, vision, FSA, company paid basic life insurance and 401K.
Octapharma Plasma Inc. is an Equal Opportunity Employer