Position : Quality Assurance Specialist

Location : Farmington, NM

Purpose

The Quality Assurance Associate supports the center management team by ensuring that center operations are compliant with industry quality standards and regulations meeting center production goals. 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 cGMP 21CFR.

Key Accountabilities

1. Assists with review of manufacturing activities, determines if records are in compliance with SOP and regulatory requirements, and ensures corrective actions as needed.

2. May perform final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.

3. Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.

4. Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.

5. 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.

6. Assists management and training staff in communicating SOP and regulatory changes to staff and ensures documentation of training is complete.

7. Assists in analyzing tracking and trending data and determines appropriate actions to improve trending.

8. 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.

9. Reviews incoming softgoods and medical supplies to ensure accurate receipt and suitability for use.

10. Other job related responsibilities as required.

Qualifications

1. Bachelor's degree in life science or related field preferred.

2. Minimum three years' quality systems experience in a regulated environment; or equivalent combination of education and experience.

3. Knowledge of FDA regulations and standards preferred.

4. Strong written and verbal communication skills.

Physical and Mental Working Conditions

1. Frequently performs work while sitting or standing.

2. Frequently exposed to bloodborne pathogens and may be required to wear personal protective equipment.

3. Occasionally exposed to working environment > - 30P o PC. and appropriate personal protective equipment.

4. May be required to work flexible work schedule, including weekends and holidays.

5. Occasionally required to lift, push and pull up to 25 pounds.

6. Required to communicate and interact with employees and donors.

Your Job

• Ensuring the plasma collection center operates within the scope of Quality procedures and regulatory guidelines.

• Using business metrics to analyze, track and trend center performance to business objectives and addressing deficiencies through continuous improvement initiatives.

• Setting high standards for service excellence and holding others accountable for delivering to those standards.

• Participating in internal and external regulatory audits and addressing non-compliance observations.

• Performing final Quality review of all documents related to release and shipment of plasma products.

The Requirements

• Associates or bachelor's degree in Business Administration, Life Sciences or related field preferred.

• Minimum of three years' experience in a regulated Quality systems environment or plasma collection center.

• Demonstrated knowledge of FDA and EU blood products regulations and standards.

• Proven ability to influence diverse groups of people to accomplish targeted performance expectations.

• Previous experience hosting or participating in regulatory audits

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.