Quality Systems​/Continuous Improvement Contractor

Quality Systems / Continuous Improvement Contractor

Location:

Swiftwater, PA

Duration:

8

Months+ Extension

Domain Exposure:

Consumer Discretionary

Client:

To Be Discussed Later

Employment Type:

W-2, 1099, C2C

Work Authorization:

US Citizen, Green Card, H-1B, OPT-EAD, CPT, Other

Job Title: Quality Systems / Continuous Improvement Contractor

Location: Swiftwater, Pennsylvania

Duration: 8 Months + Extension

Bill Rate: $72/hour (C2C)

Job Type: W-2, 1099, C2C

Client: To Be Discussed Later

Work Authorization: US Citizen, Green Card, OPT-EAD, CPT, H-1B, H4-EAD, Other

The Quality Systems / Continuous Improvement Contractor will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling. This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.

• Serve as the CAPA and Change Control point of contact supporting Formulation and Filling improvement initiatives.
• Independently manage CAPA and Change Control actions, ensuring accurate documentation and timely closure.
• Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective/preventive actions.
• Partner with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.
• Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (e ), Opstrakker, and factory improvement initiatives.
• Support continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.
• Monitor and communicate key performance metrics and identify opportunities for process improvement.
• Author and maintain high-quality protocols, technical reports, investigations, CAPAs, and Change Controls.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
• Support regulatory inspections and audits as required.

• Experience:
  
  Minimum 3–5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with Formulation, Filling, Lyophilization, and/or Inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and Root Cause Analysis.
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Strong technical writing, project management, problem-solving, and cross-functional communication skills.
• Proficiency in Microsoft Excel, Word, and PowerPoint.

We are an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, national origin, citizenship/ immigration status, veteran status, or any other status protected under federal, state, or local law.