Quality Assurance Supervisor

Octapharma Plasma Cleveland , OH 44114

Posted 1 week ago

If you are interested in an exciting career in the biopharmaceutical or medical field you've come to the right place. At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding. Whether you are just beginning your career or you have experience in the medical field, we have many exciting opportunities for you to consider.

The Quality Assurance Supervisor is responsible for the overall quality program of the Donor Center.

Additional Responsibilities Include:

  • Provides advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality

  • Has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion

  • 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

  • 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; 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; determines 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 quality assurance-related work 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 at all levels

  • Must have excellent organizational skills and be detail-oriented

  • Must have ability to interpret SOP's and regulatory requirements

  • Must have 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

  • Required to enter an environment with a temperature of -30C or colder

  • Exposure to various odors and chemicals; human source products and various chemicals

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Quality Assurance Supervisor

Octapharma Plasma