QC Analyst - Microbiology (Temporary, 1st shift, Fri-Sun 6am-6:30pm)

Job Summary

The QC Analyst contractor will be responsible for routine and non-routine QC sampling and testing of controlled environments, critical utility systems, and production processes operating in a GMP laboratory. This position works a first shift, 12-hour schedule, Friday-Sunday, 6am-6:30pm fully on-site schedule with occasional holiday support required.

Essential Job Functions

• Perform QC testing of in-process and product samples while adhering to standard operating procedures (SOPs).
• Ensure routine QC Environmental Monitoring and Microbiology sampling/testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, are performed in compliance with all industry regulations and standards.
• Write, revise, or review SOPs for quality control operations to assure regulatory requirements and industry standards are met.
• Support aseptic processing activities.
• Complete documentation, perform data entry and review in accordance with Good Manufacturing Practices (cGMP) applying ALCOA+
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Sampling and testing of critical utility systems including water and gas supplied to manufacturing areas.
• Perform data trending and aid in compilation of trend reports.
• Prepare samples for shipment to contract testing laboratories and review of testing data reports, as required.
• Conduct non-conformance and Out of Specification and laboratory investigations and environmental monitoring excursion investigations
• Troubleshooting equipment and microbiological testing methods.
• Training of other Analysts within the department within scope of knowledge.
• Support internal and cross-functional project related activities as needed.

Special Job Requirements

• Adaptability required as work schedule may change based on business needs.
• Work outside of normal business hours, including nights, weekends and holidays, when necessary.
• Criminal background check required (completion by staffing agency satisfies this requirement).
• Other duties as assigned.

Knowledge, Skills and Experience

Education / Certifications / Licenses

• A minimum of a Bachelor’s degree in Life Science or related science

On-the-job Experience

• 3+ Years of QC Microbiology Experience

Skills / Abilities

• Strong understanding of required laboratory practices including aseptic technique
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
• Must be able to demonstrate ability to gown aseptically
• Good/effective communication and organizational skills with the ability to work well with others and independently.