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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality evaluation and compliance, including knowledge of cGMP and regulatory requirements. Proficient in inspection techniques, statistical sampling concepts, and effective communication skills.
Highest-signal resume keywords
Quality EvaluationCGMP KnowledgeStatistical Sampling ConceptsInspection ExperienceEffective Communication Skills
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 Attributes EvaluationChemical Testing CoordinationLabel Compliance VerificationIncident ReportingProduct InspectionLabeling Specification PreparationANSI Sampling Plans AuditingTechnical Drawing InterpretationRecord KeepingVisual Inspection Certification
Soft Skills
Keen Assessment SkillsTactful Human Relations SkillsAbility to Work with Limited Supervision
Tools & Technologies
Quality Management SystemsStatistical Software
Certifications & Qualifications
Visual Inspection Certification
Industry Keywords
CGMPRegulatory ComplianceMaterial Release ProceduresPackaging InspectionDistribution Operating Procedures
About the role
Key responsibilities & impact- Evaluate critical quality attributes, including visual, dimensional, and functional attributes, for quality-managed materials
- Coordinate required chemical and/or biological testing
- Execute approved usage decisions and release materials for facility use
- Determine acceptability of labels, chemicals, raw material components, and other materials
- Issue and track Incidents/Raw Material Reports for discrepant material
- Quarantine product according to approved disposition procedures
- Monitor changing regulatory-agency requirements affecting materials evaluation and material release
- Physically inspect products and review documentation and labeling for shipment compliance
- Verify compliance with specifications, product licenses, CFR, and customer-specific requirements
- Reconcile all released products, including labels, plasma, and raw material components
- Prepare, review, and revise labeling specifications, raw material criteria, and outgoing shipment specifications
- Inspect product final-container reserve samples according to approved procedures
- Perform Packaging-area quality representative duties, including sampling, auditing, and quality decisions
- Audit final product batches using designated ANSI sampling plans
- Conduct reserve sampling, post-pack identity sampling, packaging commodity verification and reconciliation, line-clearance verification, and stability-sample inspection
- Serve as a trainer and Subject Matter Expert for new employees at the Associate level
- Perform other duties as assigned
Requirements
What you’ll need- Minimum of an Associate's degree with an emphasis in sciences or mathematics, or an equivalent combination of education and experience
- Minimum of one year of related experience required for the QO Associate Materials Evaluation position
- Prior inspection experience, such as manufacturing components or packaged goods
- Keen assessment skills and ability to distinguish insignificant from significant deviations
- Ability to learn and understand statistical sampling concepts
- Computer skills
- Ability to read and understand technical drawings
- Effective written and verbal communication skills with proper grammar
- Ability to maintain neat, accurate, and complete records
- Tactful human relations skills
- Extensive knowledge of cGMP, company specifications, and distribution operating procedures
- Ability to wear required protective eyewear, garments, and gloves
- Ability to work with limited supervision and defend decisions based on specifications and procedures
- Near vision correctable to at least 20/20 in one eye and 20/40 in the other eye
- No color blindness; excellent color and depth discrimination
- Ability to lift up to 50 lbs
- Ability to successfully pass certification requirements for product final container visual inspection
- Directly related experience or a combination of directly related education, experience, and/or competencies may be considered in place of stated requirements
Benefits
Comp & perks- Equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, or disability
- Required safety equipment provided for work with raw material chemicals (protective eyewear, garments and gloves)
