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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in environmental monitoring and microbiology fundamentals, with a strong focus on compliance with FDA regulations and GMP standards. Proficient in data management using SAP and skilled in maintaining accurate documentation and logs.
Highest-signal resume keywords
Environmental MonitoringMicrobiology FundamentalsFDA Regulations ComplianceData Management in SAPAseptic Techniques
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Environmental Monitoring SamplingData Entry in SAPMicrobiology TechniquesAseptic TechniquesEquipment CalibrationDocumentation MaintenanceInventory ManagementSample TrackingHousekeeping FunctionsAnalytical Problem-Solving
Soft Skills
Strong Attention to DetailOrganizational SkillsInterpersonal SkillsProactive AttitudeGood Judgment
Tools & Technologies
MS Office SuiteSAP
Industry Keywords
GMP EnvironmentPharmaceutical IndustryEnvironmental MonitoringFDA RegulationsClean Room Environment
About the role
Key responsibilities & impact- Collect environmental monitoring samples in manufacturing processing areas, including viable, non-viable, surface, personnel, water and gases
- Prepare equipment and supplies required for environmental monitoring
- Share responsibilities for monitoring equipment maintenance and calibration
- Perform housekeeping and support functions, including inventory of consumables and reagents
- Compile and enter data into SAP for reporting and trending
- Review test results against specifications
- Maintain daily sample logs for timely testing and sample tracking
- Maintain instrument usage and calibration logs
- Follow procedures and practices according to FDA regulations
- Maintain strong documentation according to FDA regulations
- Adhere to departmental and corporate safety policies
Requirements
What you’ll need- Associate degree in Microbiology, Biology or closely related scientific discipline is required; Bachelor's degree preferred
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
- Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred
- Basic understanding of microbiology fundamentals, aseptic techniques and environmental monitoring
- Strong organizational, analytical, and problem-solving skills
- Proactive, results oriented, and strong attention to detail
- Self-starter with 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
- Excellent verbal and written communication skills in English
- Computer literacy and proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Flexibility with working hours/shifts for 24-hour, 7-day plant operation
- Ability to lift or push up to 25 pounds
- Ability to stand and/or sit for extended periods, up to four hours at a time
- Ability to gown and enter an aseptic/clean room environment at 65°F
- Manual dexterity for clerical functions such as typing, mouse use, copying and faxing
- Ability to work at a computer and view a video display terminal less than 18 inches away for up to four hours at a time
- Ability to read and review documents for up to four hours at a time
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