Job 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 Technician
JOB SUMMARY:
This position performs quality assurance and control functions and supports the Quality
Assurance Supervisor in ensuring compliance with internal and external regulations, protocols,
and policies.
ESSENTIAL JOB FUNCTIONS:
· 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.
· Performs QA review of training records to ensure compliance with SOP, training manual and regulations.
· Performs QA review of deviation reports.
· Ensures the Donor Center’s licenses and certificates are in-date and valid.
· Reviews donor record files daily per DCOP instruction.
· Reviews of all product destruction records for compliance with SOPS.
· Stages plasma units for shipment, requires pulling plasma cases in and out of freezer.
Performs Quality Control Procedures
· Performs a QA review of reactive donor record files, including look-back records for compliance with SOP.
· Reviews Quality Control checks on equipment, reagents, and records have been performed as required and are in acceptable ranges.
· 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.
· Assists in maintaining the established quality system under any requirements that affect the center and help ensure that all operations in the center are in compliance with the Company’s Quality Program.
· Assists in, conducts, and evaluates center training and orientation programs.
Job Requirements
JOB SPECIFICATIONS:
· Associates degree in applicable field of study preferred or equivalent job experience.
· 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.
· 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 operate computer software including keyboard, typewriter, and calculator.
NOTE: A QAT backup may be required by specific regulatory agencies. Their experience and background must be approved by Quality Management.
PHYSICAL REQUIREMENTS:
· Ability to sit or stand for extended periods for up to four (4) hours at a time.
· Ability to tug, lifts, and pulls 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 -40°C.
· Specific vision abilities required by this job include close vision, color vision, depth perception and the ability to adjust and focus.
· Must wear personal protective clothing (PPE) such as lab coats, gloves, and face shields at all times when working in production areas.
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.
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