Quality Assurance Specialist

KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including:- Medical, vision and dental insurance- Life and AD&D insurance- Paid holidays- PTO accrual- and much morePlease let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may havePlease note that salary ranges are calculated based off levels of: relevant experience, education and certifications.JOB SUMMARYResponsible for promoting quality standards within the center and ensuring quality policies and procedures are followed by center personnel under the direction of the Quality Assurance Manager. Escalates any non-compliance that affects donor safety or plasma quality to Quality Management. Operates within the scope of EU Guidance on Good Manufacturing Practice (GMP) and FDA cGMP 21CFR.ESSENTIAL JOB FUNCTIONSEvery effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.MAIN DUTIES AND RESPONSIBILITIESCoreAssists with review of manufacturing activities, determines if records are in compliance with SOP and regulatory requirements, and ensures corrective actions when appropriate.Ensures plasma release and shipments meet specifications and requirements as defined by customers and in DCOPs. When necessary, authority to stop production and/or release of product.Ensures general understanding of all applicable state and federal regulations as well as industry and corporate policies.Reviews and investigates final shipment release deviations including accurate labeling and documentation of shipments.Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.Reviews compliance issues with appropriate staff and their supervisors.Provides accurate reports of the facility’s compliance to Quality Assurance Manager (QAM), Regional Manager and/or VP of QA/RA.Assists in analyzing, tracking, and trending data and determining appropriate actions to improve trending.Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.Ensures correct documentation and computer use for archiving or backup, including donor files.Ensures supplies and equipment are received, maintained, stored, and documented to meet quality regulations.Reviews qualification, calibration and maintenance, repair and operation of equipment and documentation of use.Ensures QC checks are performed on all units and cases of products stored and shipped by the center.Ensures QC checks are performed as required and, in acceptable ranges, for controls and test reagents.Encourages and participates in continuous quality improvement process.Monitors, prepares, and submits epidemiological data for PPTA or in corporate required format(s).Ensures all staff is trained and training completion maintained for documenting competency to perform all assigned tasks. Assists QAM evaluating the following:Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive the recording and reporting of test results by reviewing work sheets, quality control records, preventive maintenance records, and other records and entries (both manual and automated).Performing written tests to assess problem solving skills, knowledge of DCOPs, and performance using internal blind specimens and external proficiency test minimum acceptable scores, performance, and remedial measures identified to correct inadequate performance on competency evaluations which are documented and retained in personnel summaries to provide useful information to correct individual or group performance problems identified, if any.Ensures CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.GeneralMust be able to execute all terms and conditions set forth in the KEDPLASMA Employee Handbook, including, but not limited to:Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace.Comply with company Global Code of Conduct and company’s policies and procedures and all the applicable regulations.Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code.Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager.Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors.Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services. Complete all assigned tasks in a timely manner as instructed by supervisor/manager.Adhere to work schedules in completing and performing assigned tasks.Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage.Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a calm environment.Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest.Treat donors, visitors, and co-workers with courtesy, respect, and dignity.Perform any miscellaneous duties or work assignments, as required.PRIMARY CONTACTSCenter Management, donors, employees, auditors, inspectors, vendors, corporate staff, and visitors.REQUIREMENTS Education, Qualifications & ExperienceBachelor’s degree in life science or related field, preferred.Minimum two years’ experience in a plasma center preferred.Minimum one-year experience in a regulated industry. cGMP experience, preferred.Three to five years of working experience in a biomedical field preferred.Knowledge of FDA and EU regulations and standards preferred.Physical RequirementsWork is primarily light in nature, with exerting up to 25lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.Working ConditionsPrimarily inside with well-lighted and well-ventilated areas.Exposure to Blood Borne Pathogens.Periodic exposure to an environment with a temperature of -40°C for short periods of time.