Quality Assurance Technician (New Center)

at  Octapharma Plasma Inc

Want to be a part of something exciting? Help Octapharma Plasma open our next Donor Center! At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding.
We own and operate plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world’s largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient care and medical innovation for over 30 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide.

QUALITY – REGULATORY - OPERATIONS

We are seeking a Quality Assurance Technician to join our growing biopharmaceutical company and assist in opening our newest Donor Center. Reporting into the Quality Assurance Supervisor, you will perform quality assurance and control functions and assist in ensuring compliance with internal and external regulations, protocols, and policies.
Additional responsibilities of the Quality Assurance Technician role include:
• Reviews SOPs to ensure that the most recently approved SOP procedures and forms are in the center procedure manuals and in use.
• Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.
• Reviews equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.
• Reviews freezer and refrigerator charts and temperature records for compliance with SOP.
• Performs QA review of external sample and product shipment releases and shipping records as well as stages plasma units for shipment. (Requires pulling plasma cases in and out of freezer)
• Performs QA review of training records to ensure compliance with SOP, training manual and regulations as well as assist/conduct center training and orientation programs.
• Ensures the Donor Center’s licenses and certificates are in-date and valid.
• Reviews of all product destruction records for compliance with SOPS and QA review of deviation reports
• Performs a QA review of reactive donor record files, including look-back records for compliance with SOP and daily record checks per DCOP instruction.
• Performs audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems.
• Attends and assists in all audits and ensures that all audits (internal and external) are performed, documented, reviewed, and closed.

JOB REQUIREMENTS

Qualified candidates of this role must offer an Associate’s degree in an applicable field of study is preferred, however, equivalent job experience will be considered. You must offer strong organizational skills, attention to detail and excellent interpersonal skills.
Other requirements of the Quality Assurance Technician role include:
• Must have a minimum of one (1) years related work experience, preferably in a donor center.
• One (1) year work experience in biologics quality assurance preferred.
• Must have legible handwriting.
• Must possess knowledge and aptitude to learn various computer software; such as word processing, spreadsheets, or other related software programs.
• Ability to operate computer software including keyboard, typewriter, and calculator.