Department: Azzur Labs, LLC
Azzur Labs is seeking a Quality Specialist for their PA Laboratory. The Quality Specialist I supports the company’s quality assurance and control programs. The Quality Specialist I is responsible for document review and control, inventory control, and quality control of incoming materials. The Quality Specialist I will assist the Quality Director in assuring that the quality management system is implemented and followed.
- Ensures all incoming materials are tested and found to be of acceptable quality before use.
- Responsible for assisting in the conduct of internal audits.
- Assists in conducting investigations of laboratory deviations and client exceeded concern levels.
- Maintains training records and documentation.
- Reviews documentation, such as raw data and reports (Environmental monitoring, water, media fill, bioburden), logbooks (beginner to intermediate level), quality control records, and quality assurance records for completeness, accuracy, and compliance with methods, protocols, guidelines, regulations and Azzur Labs LLC quality systems.
- Assures proper control of laboratory testing as needed for review.
- Maintains familiarity with laboratory testing as needed for review.
- May draft or review client notifications of exceeded levels.
- Collaborates with the implementation, maintenance, and improvement of quality systems.
- Reads standards, journals, and publications to keep abreast with requirements and developments in applicable technologies.
- At least 1 year of experience in a regulated industry, preferably in quality or laboratory operations.
- A related or equivalent experience by being substituted.
- 1-year experience in a quality role.
- Previous experience in the batch record or documentation review.
- Desired background in Microbiology
- American Society for Quality Certified Quality Technician or other certification.
Skills (including typical mental demands)
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
- Computer skills
- Mathematical skills
- High School Diploma or Equivalent
- Bachelor of Science or Bachelor of Arts in a science field
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.