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 ImprovementIdentify and document process variations from standard proceduresLead thorough investigations to determine root causesPartner with teams across departments to develop effective solutionsImplement corrective and preventive actions that enhance our processesEnsure Documentation ExcellenceDevelop clear, accurate records of investigations and resolutionsPrepare concise reports for leadership and regulatory authoritiesMaintain documentation that meets Good Documentation Practices (GDP)Champion ComplianceApply industry standards and regulatory requirements to all deviation managementSupport internal and external audits with organized documentationParticipate in continuous improvement initiatives based on deviation trendsGrow Your ExpertiseAnalyze patterns to find opportunities for process enhancementParticipate in professional development to strengthen your quality management skills

Education/Eperience

Bachelor's degree in Life Sciences, Engineering, or Quality Management3+ years of experience in deviation involvement/writing, quality assurance, or related rolesQuality Management certification (Six Sigma, ASQ) is preferredExperience with electronic documentation systemsFamiliarity with GMP and GLP practicesKnowledge of regulatory requirements (FDA, EMA, ISO) and industry standardsStrong analytical thinking and problem-solving abilitiesExcellent interpersonal skills for cross-functional collaborationExperience 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.