This position is responsible for promoting quality standards within the center and ensuring that quality policies and procedures are followed by center personnel. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA
Responsibilities:
Assists with review of manufacturing activities, determines if records are in compliance with SOP and regulatory requirements
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Ensure and ensures corrective actions as needed.
May perform final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.
Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.
Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.
Assists with or performs ongoing focused audits to ensure employees correctly perform procedures; identifies deficiencies and works closely with training staff to correct any issues noted.
Assists management and training staff in communicating SOP and regulatory changes to staff and ensures documentation of training is complete.
Assists in analyzing tracking and trending data and determines appropriate actions to improve trending.
Reviews center logs and records to ensure information is accurate and/or legible as outlined in the Quality System SOP and ensure corrections are made as needed.
Reviews incoming softgoods and medical supplies to ensure accurate receipt and suitability for use.
Other job related responsibilities as required.
Working hours: 4:00 PM - 12:30 AM
Skills:
High Schol Diploma GED, Bachelor's degree preferred.
Strong written and verbal communication skills.
Education:
High School
Experience:
0-1 years
Qualifications:
Minimum 2-3 years' quality systems experience in a regulated environment; or equivalent combination of education and experience.
Knowledge of FDA regulations and standards preferred.
Apply online at : www.spheiron.com/apply and then,
call us at 956-961-4298
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
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At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including health, and an incentive and recognition program (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Spherion's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Spherion representative for more information.