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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in immunohematology manufacturing and regulatory compliance, with strong leadership skills to guide teams in a biotechnology environment. Proficient in managing production operations, troubleshooting technical issues, and ensuring adherence to quality systems and safety standards.
Highest-signal resume keywords
Immunohematology Manufacturing ExpertiseRegulatory Compliance (GMP, FDA, ISO)Leadership in Regulated EnvironmentsDeviation Investigation ManagementAnalytical Testing Coordination
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Immunohematology TechniquesCGMP KnowledgeQuality Systems RequirementsTechnical Process TroubleshootingBatch Record ReviewCAPA ManagementProduction Operations ManagementAnalytical Testing ExecutionEquipment Operation UnderstandingLean Manufacturing Knowledge
Soft Skills
Team LeadershipCoaching and MentoringResult-Driven TeamworkCommunication SkillsProblem-Solving
Tools & Technologies
SAPMicrosoft WordMicrosoft ExcelMicrosoft Outlook
Industry Keywords
Biotechnology IndustryMedical Device IndustryRegulated EnvironmentImmunohematology5S Methodology
About the role
Key responsibilities & impact- Guide and lead department associates executing daily operations
- Act as point of contact for assigned production runs from start to finish
- Assign production support activities according to the schedule
- Ensure production operations comply with Grifols policies, GMP, FDA, ISO, and safety requirements
- Coordinate pre-production checks and activities
- Troubleshoot and resolve technical process issues
- Coordinate and execute analytical testing activities
- Assist with batch record review and corrections
- Review, initiate, and approve departmental change requests
- Initiate production-related deviations in the quality system
- Manage investigations and implement corrective actions
- Own and manage assigned CAPA actions
- Coach and mentor associates and foster result-driven teamwork
- Perform supervisory activities as needed
- Lead Immunohematology manufacturing activities, including pre-production and post-production tasks
- Lead Reagent Bulk, Fill, and Packaging Technicians in fill/finish manufacturing
Requirements
What you’ll need- At least a bachelor’s degree in biological or physical sciences
- At least 6 years of experience in the biotechnology/medical device industry
- At least 5 years of experience working in a regulated environment
- At least 2 years of leadership experience in a regulated immunohematology or similar biological-based manufacturing environment
- Expertise in immunohematology-related manufacturing
- Thorough knowledge of cGMPs, equipment, technology, and quality systems requirements
- Computer skills, including Word, Excel, and Outlook
- Strong technical knowledge of commercial immunohematology techniques
- Experience supporting and/or leading deviation investigations
- Understanding of GMP, FDA, and ISO regulatory requirements
- Ability to understand the operation of all equipment associated with the supervised process
- Ability to lift and/or push 35 lbs
- Ability to work variable shifts
- SAP knowledge is a plus
- Knowledge of 5S and Lean manufacturing is a plus
Benefits
Comp & perks- Up to 5% 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