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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biologics processing and FDA regulations, with a strong focus on cGMP compliance and operational leadership. Capable of training personnel and managing production schedules in a clean-room environment while ensuring safety and quality standards are met.
Highest-signal resume keywords
Biologics ProcessingCGMP ComplianceFDA RegulationsLeadership SkillsClean-Room Manufacturing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process AnalysesUltrafiltration OperationChromatography OperationCIP Systems OperationSIP Systems OperationCentrifuge OperationTouchscreen OIT OperationEquipment Setup and OperationDocumentation CompletionSafety Policy Adherence
Soft Skills
Attention to DetailInterpersonal SkillsProactive AttitudeResults OrientationTeam Collaboration
Tools & Technologies
MS OfficeForkliftsTractorsPower Equipment
Certifications & Qualifications
High School DiplomaGEDAssociate’s DegreeApplicable Certification
Industry Keywords
PharmaceuticalGMPFDA Regulated EnvironmentBiological FluidsPersonal Protective Equipment
About the role
Key responsibilities & impact- Oversee coordination and operations of the production schedule, shift, and personnel
- Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals
- Follow procedures and practices according to FDA regulations
- Complete documentation according to FDA regulations
- Follow departmental and corporate safety policies
- Perform facility and equipment cleaning
- Work in a sanitized clean-room manufacturing environment
- Perform basic process analyses including pH, refractive index, turbidity, and conductivity measurements
- Operate ultrafiltration units, chromatography columns, CIP systems, SIP systems, centrifuges, and touchscreen OITs
- Train entry-level personnel
- Perform complex and advanced job tasks
- Assist management with coordinating and scheduling day-to-day department operations
- Serve in a leadership role in the absence of direct supervision
- Perform other assigned duties
Requirements
What you’ll need- High school diploma or GED required
- Associate’s degree, applicable certification, and/or military veterans preferred
- Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment
- Demonstrated leadership skills with ability to motivate, guide, train, coach and develop department personnel
- Comprehensive knowledge of cGMPs, FDA regulations, and industry guidelines
- Ability to work independently with minimum supervision
- Proactive, results oriented, and strong attention to detail
- Strong work ethic and good judgment
- Ability to prioritize and manage multiple tasks to meet deadlines
- Strong interpersonal skills and ability to interact with personnel at all levels in a team environment
- Must be able to read, write, and speak English
- Computer literacy and proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Flexibility to work hours/shifts for 24-hour, 7-day plant operation
- Ability to work in a clean-room manufacturing environment with exposure to biological fluids, chemicals, electrical equipment, machinery, noise, extreme cold, and confined spaces
- Ability to operate forklifts, tractors, and power equipment
- Ability to use required personal protective equipment
- Ability to stand and walk for 4–6 hours per day
- Ability to bend and twist neck and waist for 4–6 hours per day
- Frequent hand and foot movement with precise finger, hand, and wrist coordination
- Ability to frequently lift and carry 15–44 lbs and 45 lbs, with maximum lift of 50 lbs
- Essential hearing acuity, color/depth perception, and correctable far vision
Benefits
Comp & perks- Up to 5% company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Professional growth and career progression opportunities
- Family-like company culture