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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality assurance and regulatory compliance, with a strong understanding of the Code of Federal Regulations, European Pharmacopoeia, and CLIA/COLA/PPTA regulations as they apply to Source Plasma. Capable of conducting audits, developing Standard Operating Procedures, and effectively communicating with regulatory authorities.
Highest-signal resume keywords
Quality Management Systems ReviewsRegulatory Compliance ExpertiseAudit Planning and ResponseStrong Written and Verbal CommunicationCritical Thinking and Attention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceRegulatory Inspection SupportData Integrity AssessmentRisk Management AssessmentCAPA Plan DevelopmentStandard Operating Procedure AuthoringAudit Response DevelopmentProcedural Compliance EvaluationDeviation AnalysisProcess Improvement Identification
Soft Skills
Interpersonal SkillsOrganizational Skills
Industry Keywords
Code of Federal RegulationsEuropean PharmacopoeiaCLIACOLAPPTASource PlasmaFDAEMAHealth CanadaQuality Management Systems
About the role
Key responsibilities & impact- Execute critical actions enforcing adherence to corporate quality and compliance processes
- Conduct quality management systems reviews, data integrity assessments, and risk management assessments
- Lead donor centers and shared services through external regulatory and customer inspections
- Direct audit planning and response activities
- Oversee Plasma Master File updates to ensure donor center compliance
- Develop Site Master Files required for external EMA inspections
- Deliver expert on-site and remote support during regulatory inspections
- Develop, author, and critically review external and internal audit responses and CAPA plans
- Coordinate and author final regulatory inspection responses for FDA, EMA, CLIA/COLA, PPTA, State authorities, Health Canada, and internal compliance auditors
- Oversee customer audits and provide customer-requested documentation
- Conduct QMS assessments evaluating procedural compliance, process robustness, and operational risk
- Evaluate procedures and processes against Domestic and European regulations
- Identify systemic improvement opportunities through audit-findings analysis
- Support Change Requests and author Standard Operating Procedures
- Evaluate deviations and analyze tracking and trending data
- Represent the department on organizational initiatives and process improvement teams
- Travel for audits, meetings, trainings, and center visits
Requirements
What you’ll need- Bachelor’s degree required
- Minimum 5 years experience in quality assurance related field
- Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma
- Must know the European Pharmacopoeia (EP) as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s)
- Must know CLIA/COLA/PPTA regulations as they apply to Source Plasma and be able to support State required inspections as needed
- Ability to write clear, concise, logical responses to regulatory authorities
- Strong interpersonal skills
- Effective written and verbal communication skills
- Critical thinking and attention to detail
- Ability to organize tasks and projects effectively
- Knowledge of current regulatory standards
- Ability to travel 25% or greater if demand requires; position requires 50% and up travel for occasional meetings, trainings or center visits for audits
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture