Quality Assurance Associate

ClinLab Staffing; Glassboro (NJ); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

Flexible spending account

Life insurance

Vision insurance

Parental leave

Referral program

Employee assistance program

401(k) matching

Job summary

A staffing agency in the pharma industry is seeking a Quality Assurance Associate to oversee the quality in facilities and manage market complaints. This role requires an Associate’s degree in a science-related field and 3-5 years of experience in a QA role. Competitive benefits include health insurance, paid time off, and a 401(k) plan. Must be able to travel at least 20% of the time.

Qualifications

• 3-5 years experience in a QA role at an FDA-regulated company.
• Ability to write market complaint investigations.

Responsibilities

• Document and investigate market complaints from customers.
• Prepare market complaint reports and training on SOPs.
• Assist in internal and external audits.

Skills

Critical thinking

Effective communication

Problem-solving/troubleshooting

Ability to multi-task

Basic knowledge of Microsoft Office

Ability to work closely with co‑workers

Organizational skills

Ability to travel

Education

Associate’s degree in science-related field

Job description

Overview

The Quality Assurance Associate role is to handle market complaints and oversee quality in our facilities (warehouses and production plants, etc.) including Quality Control activities.

Base Pay Range

$50,000.00/yr - $60,000.00/yr

Location

NY, NJ, PA, MD, and DE

Responsibilities

• Document, investigate, and participate in market complaints received from customers.
• Prepare market complaint investigations with scientifically sound write‑ups through coordination with different departments and stakeholders.
• Write appropriate responses to customers as needed addressing their concerns.
• Prepare trend reports for market complaints received from customers.
• SOP/Training: Write, revise, and provide training to new and existing employees for Standard Operating Procedures, testing specifications, protocols, and reports as needed.
• Manage training software, enter training records, and trend all employees’ training.
• Production/Warehousing:
  • Inspect procedures and logbooks to ensure they are efficient and comply with regulations.
  • Assist in monthly internal audits.
  • Record all data and results in specified forms, records, or log books with accuracy.
  • Assist in reviewing and ensuring all completed manufacturing records are free from error before product release.
  • Assist in product release activities after thorough review of testing data and batch manufacturing records.
  • Assist in internal and external audits with management guidance.
  • Ensure and maintain retained samples.
  • Pull samples.
  • Oversee and inspect production lines throughout production runs.
  • Test and monitor the facility environments for microbial contaminants.
  • Water system, air monitoring, drains, hoses and sinks.
  • Inspect, test, and release cleaned equipment.
  • Work closely with sanitation personnel.
  • Maintain the trending data/results generated from the environmental monitoring and cleaning equipment verifications.
  • Send raw materials, components, finished products, and stability samples to appropriate 3rd party laboratories.
  • Maintain a clean working environment.
  • Assist with filing of QC and QA documents.
  • Assist with cleaning/method validation studies.
  • Support in handling and disposing of product returns.
  • Discover opportunities for continuous improvement.
  • Participate in other duties as assigned by the Quality management.

Skills

• Associate’s degree in science‑related field.
• 3‑5 years experience in a QA role at an FDA‑regulated Pharmaceutical, Nutraceuticals, or Food industry company.
• Critical thinking and ability to write market complaint investigations.
• Basic knowledge of Microsoft Office.
• Ability to work closely with co‑workers.
• Effective communication and organizational skills.
• Strong problem‑solving/troubleshooting skills.
• Ability to multi‑task in a fast‑paced environment.
• Ability to travel at least 20% of the time.

Benefits

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance