Analyst Jobs

About The Position

Requirements

• Bachelor or Master Degree in an applied science (microbiology preferred).
• 5 - 7 years of experience preferred, or equivalent level of skill and experience.
• Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
• Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (broth/agar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring.
• Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
• An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required.
• Require good written and verbal communication skills, good team work skills
• Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.

Nice To Haves

• microbiology preferred
• 5 - 7 years of experience preferred
• Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.

Responsibilities

• Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
• Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers. Testing includes Sterility, Bioburden, endotoxin (gel clot), growth promotion, biological indicator testing.
• Environmental Monitoring, Utilities and Gas sampling and testing.
• Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement, Microbial Limits testing, growth promotion.
• Executes validation studies, obtain and interpret validation data following microbial guidance documents.
• Coordinates and processes departmental change controls
• Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs
• Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Compiles and analyzes EM/Utility Data and write Quarterly/Annual Reports
• Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory.
• Uses GMP and scientific expertise to lead internal (department and site) audit activities.
• Mentor and provide guidance to junior personnel.
• Performs laboratory instrument calibration in accordance with established procedures.
• Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate
• Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
• Ensure critical QC metrics are consistently met for product turnaround times.
• Peer Reviews and Verification of QC data.
• Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
• Author laboratory investigations and non-conformance.
• Supports CAPA and change control through participation in project planning and collaboration.
• Works on problems of diverse scope requiring evaluation of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Receives minimal instruction on routine work, general instructions on new assignments.
• Ownership – Actively participate in self-development
• Accountability – Follow through on commitments, Situational Leadership or additional accountability tools
• Detail oriented – Able to complete required tasks and associated documentation with minimal error
• Adaptability – Maintain positive attitude in a changing work environment
• Communication – Effectively communicate with all levels of manufacturing and support staff
• Actively participate in department / level meetings
• Escalate issues through the proper channels
• Live the Core Values

Benefits

• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
• Comprehensive benefits package.