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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmaceutical manufacturing operations, including aseptic processing and cGMP compliance, while effectively supervising personnel and managing production processes. Strong analytical and problem-solving skills are essential for maintaining product quality and regulatory adherence.
Highest-signal resume keywords
Aseptic ProcessingCGMP CompliancePharmaceutical Manufacturing OperationsSupervisory ExperienceProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Protein PurificationRegulatory ComplianceBatch Documentation ReviewTroubleshootingProcess Improvement
Soft Skills
Strong Interpersonal SkillsExcellent Communication SkillsOrganizational SkillsAnalytical SkillsProblem-Solving Skills
Tools & Technologies
MS OfficeOutlookWordExcelPowerPoint
Industry Keywords
FDA RegulationsPharmaceutical IndustryGMP EnvironmentInternal InspectionsEmployee Health and Safety
About the role
Key responsibilities & impact- Supervise manufacturing processes and department personnel on a designated shift
- Ensure aseptic operations meet cGMP and company standards
- Assign tasks, check work, and maintain schedules
- Review department batch documentation for completeness and accuracy
- Initiate facility work orders for equipment repairs
- Troubleshoot processes and products to maintain aseptic processing, product yields, and facility environmental control
- Recommend and implement improvements to production methods, equipment performance, facility layout, and product quality
- Maintain compliance with regulatory requirements and current industry standards
- Generate investigation reports for out-of-specification results and out-of-procedure events
- Participate in regulatory and internal inspections and audits, including written responses
- Train, guide, coach, counsel, and develop direct reports
- Appraise and monitor department personnel performance
- Resolve employee issues in collaboration with Human Resources
- Promote employee health and safety
- Participate in interviewing and selecting department personnel
Requirements
What you’ll need- Associate’s degree required; emphasis in Biology, Chemistry, Chemical Engineering, or closely related scientific/technical discipline preferred
- Bachelor’s degree preferred
- Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA-regulated environment
- In lieu of an Associate’s degree, high school diploma or GED and a minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA-regulated environment
- In-depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing
- Comprehensive knowledge of cGMPs, FDA regulations, and industry guidelines
- Prior supervisory or leadership experience highly preferred
- Demonstrated project management skills
- Strong organizational, analytical, and problem-solving skills
- Strong attention to detail and ability to exercise good judgment
- Ability to prioritize and manage multiple tasks to meet deadlines
- Strong interpersonal skills
- Excellent verbal and written communication skills in English
- Computer literacy and proficiency in MS Office, including Outlook, Word, Excel, and PowerPoint
- Flexibility to work hours/shifts supporting 24-hour, 7-day plant operations
- Ability to work with personal protective equipment and in environments involving biological fluids, infectious organisms, chemicals, machinery, noise, and temperatures below 32°F
- Ability to lift and carry up to 35 lbs
- Ability to travel occasionally within the United States
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 8% 401(k) match
- Up to 5% 401(k) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
