Senior Quality Control Specialist (Method Validation)

Position Title: Senior Quality Control Specialist

Work Location: Social Circle, GA 30025

Assignment Duration: 6 Months (possible extension)

Position Summary:

This position functions as the technical and quality systems leader within QC Operations Support, responsible for method onboarding and implementation, change control management, CAPA ownership, equipment and material qualification, compendial compliance, data trending and statistical analysis, cross-functional project leadership, QC microbiology support, continuous improvement initiatives, and regulatory and inspection readiness.

Key Responsibilities:

1. Perform Compendial Assessments

• Evaluate pharmacopeial updates and revisions (USP, EP, JP, BP, etc.) for impact on laboratory operations.
• Assess existing analytical methods against current compendial requirements.
• Identify gaps between laboratory practices and regulatory expectations.
• Coordinate implementation of compendial changes within QC testing programs.
• Document assessments and maintain compliance records.
• Provide recommendations for method updates and procedural changes.

2. Author and Review Technical Documents

• Write and revise Standard Operating Procedures (SOPs).
• Develop protocols for method qualification, validation, verification, and equipment studies.
• Author technical reports and scientific justifications.
• Review analytical methodologies for scientific accuracy and regulatory compliance.
• Ensure document consistency with cGMP requirements and internal quality systems.
• Support document lifecycle management, including periodic reviews.

3. Design and Coordinate Analytical Method Onboarding Activities

• Develop onboarding plans for new analytical methods.
• Coordinate method transfers from development, external laboratories, or global sites.
• Establish training requirements for laboratory personnel.
• Create implementation timelines and resource plans.
• Ensure method readiness through documentation and qualification activities.
• Monitor onboarding progress and resolve implementation challenges.

4. Lead Qualification of Critical Materials, Instruments, and Equipment

• Develop qualification strategies for analytical equipment and systems.
• Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Manage qualification of analytical standards, reagents, and critical consumables.
• Ensure equipment is fit-for-purpose before routine use.
• Review qualification protocols and reports.
• Collaborate with validation, engineering, and metrology teams.

5. Oversee Change Control Management

• Initiate and manage Quality Control-related change controls.
• Conduct impact and risk assessments for proposed changes.
• Coordinate stakeholder reviews and approvals.
• Ensure proper documentation and implementation of changes.
• Verify effectiveness of completed changes.
• Track change control progress to closure.

6. Manage Corrective and Preventive Actions (CAPAs)

• Lead investigations related to laboratory deviations and quality events.
• Perform root cause analyses using structured problem-solving methodologies.
• Develop effective corrective and preventive actions.
• Track CAPA implementation and effectiveness checks.
• Ensure timely closure of quality records.
• Support inspection readiness regarding CAPA management.

7. Serve as Subject Matter Expert (SME)

• Provide technical expertise on analytical methods and laboratory systems.
• Support troubleshooting of complex testing issues.
• Advise laboratory personnel on scientific and compliance matters.
• Support regulatory inspections and audits.
• Provide scientific rationale for technical decisions.
• Mentor junior analysts and specialists.

8. Collaborate Across Departments

• Partner with Quality Assurance, Manufacturing, Validation, Engineering, Metrology, and Regulatory Affairs.
• Participate in cross-functional project teams.
• Facilitate communication between laboratory and operational groups.
• Support project planning and execution.
• Align laboratory activities with organizational objectives.
• Drive issue resolution across multiple stakeholders.

9. Drive Continuous Improvement Initiatives

• Identify opportunities to improve laboratory efficiency.
• Evaluate and implement process optimization initiatives.
• Reduce testing cycle times and eliminate non-value-added activities.
• Improve data integrity and compliance processes.
• Standardize workflows and best practices.
• Measure and report improvement outcomes.

10. Conduct Data Trending and Analysis

• Analyze laboratory performance metrics and KPIs.
• Trend analytical results, deviations, OOS, OOT, and investigation data.
• Identify recurring issues and emerging risks.
• Generate reports for management review.
• Utilize statistical tools to evaluate process performance.
• Recommend actions based on trend analysis findings.

11. Represent QC on Global and Local Projects

• Participate as QC representative for site and global initiatives.
• Support harmonization of laboratory processes across locations.
• Coordinate implementation of global quality standards.
• Share best practices with global teams.
• Lead local execution of global projects.
• Identify opportunities for process improvements and standardization.

12. Perform Other Duties Assigned by Leadership

• Support departmental strategic initiatives.
• Participate in audit and inspection readiness activities.
• Assist with staffing, training, and resource planning.
• Contribute to departmental goals and objectives.
• Provide technical leadership during critical business needs.
• Support special projects as required.

Qualification & Experience:

Education and Experience Requirements

• Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.
• Strong QC Microbiology experience preferred (testing, sampling, processes).

Key Skills, Abilities, and Competencies

• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
• Must have the ability of managing complex projects and resolving complex lab issues.
• Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
• Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
• Strong understanding of business and/or industry.
• QC Microbiology Expertise (Preferred)
• Environmental monitoring programs including data trending.
• Utility monitoring (Water, WFI, Clean Steam).
• Microbial identification.
• Growth promotion testing.
• Sterility testing.
• Bioburden testing.
• Endotoxin testing.
• Aseptic sampling techniques.
• Contamination control strategies.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $72.00/hr.