QC Analyst II

JOB SUMMARY

The QC Analyst II is responsible for environmental monitoring (EM) and microbiological testing in a GMP aseptic and non-sterile manufacturing cleanrooms, including high-potency API operations. Perform environmental monitoring and utility sampling while upholding aseptic practices, data integrity (ALCO/ALCOA ), and safety controls for potent compounds. The analyst partners closely with Manufacturing and QA to protect product quality and patient safety. Additional responsibilities include peer reviewing laboratory documentation for accuracy, performing routine laboratory and equipment maintenance in accordance with policies and procedures, and supporting documentation management. Support team members to meet group goals. Participation in special projects and/ or instrument problem-solving as needed.

• Perform environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers.

• Perform utility water sampling and testing (conductivity, TOC, bacterial endotoxins, and bioburden)
• Perform microbiological testing such as microbiological examination, endotoxin, growth promotion, etc.
• Perform sample log-in, assignment of sample tracking number, and coordinate shipment of samples to outside test labs.
• Perform QC Laboratory testing accurately, according to schedule, and as per written procedures. Record all data, observations, and QC results accurately with attention to detail.
• Accurately document all data in assay worksheets, laboratory notebooks, and electronic systems (e.g., LIMS) in accordance with ALCO data principles and cGMP guidelines
• Other duties as assigned.
• Work independently as well as collaboratively within the QC department and cross-functional departments.

• Support aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance.
• Performs enumeration, characterization, and speciation of microorganisms recovered from samples.
• Provide lab maintenance and support to ensure cGMP compliance on a regular basis.

• Take full responsibility in completing/reviewing data packets, test procedures, SOPs, and other controlled documents in a detailed and accurate fashion.

EXPERIENCE

• At minimum, 2 years of microbiological, biological, and chemical method execution within a GMP environment.
• Experience with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs.
• Previous cGMP, solid technical training, and troubleshooting experience.

COMPETENCIES

Key Competencies:

WORK ENVIRONMENT & PHYSICAL DEMANDS

This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

• Prolonged periods of standing and/or sitting at a workstation
• Must be able to regularly lift and/ or move up to 25 pounds
• Specific vision abilities include close vision, distance vision, color vision, peripheral vision, and depth perception.

EDUCATION

Minimum Required:

• Bachelor of Science in Microbiology, Biology, or a related pharmaceutical biotechnology discipline