Engineering (Non IT) and Research - Quality Engineer III

Lancesoft; Greenville (NC); On-site; USD 74,000 - 77,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Contributions

Critical Illness Insurance

Job summary

LanceSoft in Greenville, NC is seeking a Quality Engineer III to join our manufacturing quality team. The role requires evaluating facility, personnel, and documentation to ensure cGMP compliance, with a focus on aseptic processes and deviation management.

You will lead quality reviews, support root cause analyses, and drive continuous improvement initiatives while collaborating with production and QA staff.

Qualifications

• Bachelor’s degree in technology, engineering or microbiology preferred.
• A minimum of 4 years of experience in Quality Assurance/Quality Control/Operations.
• Pharmaceutical industry experience, aseptic or sterile processes preferred.

Responsibilities

• Perform daily quality assessments to ensure quality and compliance per site procedures and cGMPs.
• Troubleshoot and guide aseptic technique; assist with documentation corrections.
• Lead quality reviews and approvals of procedures, training documents, and forms of moderate to high complexity.
• Participate in deviation investigations and root cause analysis; support RAPID events.

Skills

Quality Assurance

Education

Bachelor's degree in technology/engineering/microbiology

Job description

• Description: Title: Quality Engineer III
• Location: Greenville, NC 27834
• Duration: 0-9+ months
• Shift: 6p - 6a, on a 2-2-3 rotation
• Pay Rate: $54.00 - $56.50/Hour

Job Duties / Responsibilities

• Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
• Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
• Champions quality culture by aiding personnel in understanding application of policies and controls
• Participates in RAPID event response and provides quality guidance for deviation events
• Advances deviation events to the appropriate area and quality management
• Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
• Performs quality review and approval of deviation and change control of moderate to high complexity
• Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
• Performs quality batch record review
• Aids in identification of continuous improvement opportunities;
• Participates in practical process improvement initiatives

Qualifications

• Bachelor’s degree, preferably in technology, engineering or microbiology related field required.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• A minimum of 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
• Previous experience in pharmaceutical industry;preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.E. ISO 9001)
• Ability to capture data, analyze & troubleshooting process issues, equipment problems along with production leadership
• Ability to troubleshoot process and equipment issues
• Hard-working, demonstrated ownership & responsibility.
• Ability to lead, support & empower a team/peers
• Technical Writing experience
• Professional certifications (ex: CQA) and training (Six Sigma) are a plus

Physical Requirements

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.
• Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time
• Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds.
• Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time.
• Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
• Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

Employee Benefits

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal-opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.