Job Description

Quality Assurance Associate 1

Job Summary

Responsible for completion of customer notifications (lookback notification and customer deviation reports) resulting from unsuitable test results and/or post?donation information (PDI). Customer notifications also include reporting to regulatory agencies and assisting with the determination of the final disposition of the affected products.

What Youll Do

• Collect, compile, and review data.
• Communicate with Donor Centers for required data.
• Prepare, review, and submit customer lookback notifications.
• Report Electronic Biological Product Deviation Reports (eBPDRs) to FDA.
• Generate quarantine files to apply automated product holds in plasma storage warehouse.
• Complete lookback notification peer reviews.
• Initiate and investigate corporate deviations and associated Corrective and Preventative Actions (CAPA).
• Review and report Donor Center process deviations to OPI customers.
• Document and submit customer deviation reports.
• Manage customer complaint investigations and documentation related to warehouse shipping deliveries.
• Collaborate with Corporate Validation department to investigate product temperature excursions, assess final product disposition, report, and document customer approval/denial of product shipment.
• Initiate Change Requests for SOP revisions as assigned by manager.

What It Takes

• One (1) year of quality assurance experience preferred.
• High School Diploma required; Bachelors degree preferred.
• Practical working knowledge of quality assurance.
• Knowledge of cGMP regulations, 21CFR 210, 211, and 600s.
• Knowledge of Lookback requirements on 21 CFR Part 600 preferred.
• Understanding of customer specifications to ensure compliance.
• Strong office software experience.
• Detail?oriented, able to follow detailed instructions, excellent time?management skills, well?organized, self?starter with a professional demeanor and focus on customer service.
• Consistently demonstrate that primary job duties are current; closely monitor and communicate progress to management.
• Team player, responsive to changing priorities.
• Excellent verbal communication skills.
• Internal candidates: No recurring major/critical deviations within last 6 months; no verbal warning in last 6 months; no written warnings or final written warnings in last year; no active Process Improvement Plan.

Physical Requirements

• Position works in?office at the corporate location.
• Ability to sit for extended periods.
• Ability to use a computer and office equipment.
• Occasional lifting up to 10 pounds.
• Ability to reach, bend, stoop as necessary.
• Effective verbal and written communication.
• Focus on tasks for extended periods.
• Navigate office safely (stairs, elevators).
• Use assistive devices if needed.
• Travel via automobile and/or plane up to 5%.
• Occupational exposure to blood?borne pathogens in certain facilities.

Benefits

• Formal training.
• Medical, dental, and vision insurance.
• Health Savings Account (HSA).
• Flexible Spending Account (FSA).
• Tuition Reimbursement.
• Employee Assistance Program (EAP).
• Wellness program.
• 401k retirement plan.
• Paid time off.
• Company?paid holidays.
• Personal time.

Seniority Level

Entry level

Employment Type

Full?time

Job Function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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