Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse

Job Description

The Greenville, NC site has industry-leading sterile injectable facilities providing solutions to take essential products from pre-clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointment and injectables.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Greenville, NC

RELOCATION ASSISTANCE IS NOT PROVIDED

• Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
• Must be able to pass a comprehensive background check, which includes a drug screen.

About This Role

As a Deviation Specialist, you'll lead all aspects of investigations into manufacturing process deviations, ensuring quality criteria and adherence to regulations. You'll collaborate with cross-functional teams to implement effective solutions that maintain our dedication to excellence.

What You'll Do

• Drive Quality Improvement
  • Identify and document process variations from standard procedures
  • Lead thorough investigations to determine root causes
  • Partner with teams across departments to develop effective solutions
  • Implement corrective and preventive actions that enhance our processes
• Ensure Documentation Excellence
  • Develop clear, accurate records of investigations and resolutions
  • Prepare concise reports for leadership and regulatory authorities
  • Maintain documentation that meets Good Documentation Practices (GDP)
• Champion Compliance
  • Apply industry standards and regulatory requirements to all deviation management
  • Support internal and external audits with organized documentation
  • Participate in continuous improvement initiatives based on deviation trends
• Grow Your Expertise
  • Analyze patterns to find opportunities for process enhancement
  • Participate in professional development to strengthen your quality management skills

Education/Eperience

• Bachelor's degree in Life Sciences, Engineering, or Quality Management
• 3+ years of experience in deviation involvement/writing, quality assurance, or related roles
• Quality Management certification (Six Sigma, ASQ) is preferred
• Experience with electronic documentation systems
• Familiarity with GMP and GLP practices

• Knowledge of regulatory requirements (FDA, EMA, ISO) and industry standards
• Strong analytical thinking and problem-solving abilities
• Excellent interpersonal skills for cross-functional collaboration
• Experience with quality management systems like TrackWise

Work Environment

You'll work in both professional office settings and pharmaceutical manufacturing environments. The role requires walking, sitting, and using hands for various tasks. You may occasionally experience mild physical discomfort from temperature variations, noise, or bright lights in production areas.