Senior QA Specialist - Quality Systems

Senior Quality Assurance / Quality Systems Consultant Kelly Science & Clinical is seeking an experienced Senior Quality Assurance / Quality Systems professional for an onsite contract opportunity with a leading life sciences organization in Gaithersburg, MD. Job Details

Job Title:

Senior Quality Assurance / Quality Systems Consultant

Location:

Gaithersburg, MD

Work Arrangement:

Onsite

Contract:

3-6 months initially

Schedule:

40 hours per week

Shift:

Day Shift

Pay Rate:

$70-$85/hour

Employment Type:

Contract

Supervisory Responsibilities:

None Position Overview Kelly Science & Clinical is seeking a highly experienced Senior Quality Assurance / Quality Systems professional to support a broad range of quality and compliance activities within a regulated life sciences environment. The ideal candidate will have 8+ years of experience in Quality Assurance and Quality Systems and a strong background in quality systems, supplier quality, audits, CAPA, change controls, and regulatory readiness. This opportunity is appropriate for candidates ranging from Senior QA to Senior Manager QA level. While the role requires a high level of expertise and independent decision-making, t are no direct supervisory responsibilities. Key Responsibilities

• Review and close change controls, including client notifications associated with change controls.
• Assess and approve CAPAs and effectiveness checks.
• Review and approve documents within the eQMS, including:
• Validation documentation
• Risk assessments
• SOPs
• QC specifications
• Method validations
• Facility validations
• EMPQ
• APS
• Other quality and validation documentation
• Conduct and/or support supplier quality audits.
• Review and approve supplier change notifications related to Supplier Quality.
• Conduct internal audits and review associated responses.
• Review and complete assessments of supplier-initiated notifications, including evaluation of potential product impact.
• Support FDA readiness activities, including compiling gap assessments and working with cross-functional teams on remediation efforts.
• Provide Quality support for additional projects and initiatives as needed.

The ideal candidate will have 8+ years of experience in Quality Assurance and Quality Systems and a strong background in quality systems, supplier quality, audits, CAPA, change controls, and regulatory readiness.

This opportunity is appropriate for candidates ranging from Senior QA to Senior Manager QA level. While the role requires a high level of expertise and independent decision-making, t are no direct supervisory responsibilities.

Key Responsibilities

• 
  Review and close change controls, including client notifications associated with change controls.
  
• 
  Assess and approve CAPAs and effectiveness checks.
  
• 
  Review and approve documents within the eQMS, including:
  
• 
  Validation documentation
  
• 
  Risk assessments
  
• 
  SOPs
  
• 
  QC specifications
  
• 
  Method validations
  
• 
  Facility validations
  
• 
  EMPQ
  
• 
  APS
  
• 
  Other quality and validation documentation
  
• 
  Conduct and/or support supplier quality audits.
  
• 
  Review and approve supplier change notifications related to Supplier Quality.
  
• 
  Conduct internal audits and review associated responses.
  
• 
  Review and complete assessments of supplier-initiated notifications, including evaluation of potential product impact.
  
• 
  Support FDA readiness activities, including compiling gap assessments and working with cross-functional teams on remediation efforts.
  
• 
  Provide Quality support for additional projects and initiatives as needed.
  Qualifications
  
• 
  8+ years of experience in Quality Assurance and/or Quality Systems.
  
• 
  Experience within a GxP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
  
• 
  Strong knowledge of Quality Systems, including CAPA, change control, audits, supplier quality, and document management.
  
• 
  Experience reviewing and approving validation and quality documentation.
  
• 
  Experience with supplier quality and supplier audits.
  
• 
  Experience supporting FDA readiness, inspections, or regulatory gap assessments.
  
• 
  Strong understanding of applicable FDA/GxP requirements and quality regulations.
  
• 
  Excellent written and verbal communication skills.
  
• 
  Ability to work independently and collaborate effectively with cross-functional teams.
  
• 
  Candidates with experience ranging from Senior QA through Senior Manager QA are encouraged to apply.
  
• 
  No people-management responsibilities are associated with this position.

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