Microbiology Analyst I

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 52,000 - 72,000; Full time

Job summary

RXinsider LTD. in Columbia, SC seeks a QC Microbiology Analyst I to perform microbiology testing on raw materials, in-process, and finished products according to USP methods and cGMP procedures.

The role requires aseptic technique expertise, data interpretation for release decisions, and training of QC staff. 12-hour rotating shifts with documentation and regulatory compliance responsibilities are involved.

Qualifications

• 2–4 years of experience with Microsoft Office programs and learning new systems efficiently.
• Experience with cGMP documentation systems and quality control
• Strong interpersonal, verbal, and written communication skills
• Willingness to receive training in multiple areas
• Knowledge of FDA manufacturing/regulatory quality systems and requirements
• Aseptic technique and regulatory familiarity required
• Ability to manage multiple tasks and meet deadlines

Responsibilities

• Applies microbiological analysis to raw materials, in-process, and finished products (sterility, bioburden, identification, environmental monitoring, growth promotion, media fill).
• Notifies management of all OOS and OAL results.
• Provides feedback on SOPs, forms, and logbooks to improve procedures.
• Performs routine testing to support release and company needs.
• Trains QC lab personnel on test methods.
• Interprets test results for acceptance/rejection of lots.
• Generates data for investigations and enters data into systems; trends reports.
• Reports and initiates documentation of OOS and OOT results.

Skills

MS Office

cgmp knowledge

Documentation skills

Aseptic technique

Regulatory awareness

Education

Bachelor’s degree in Biology/Microbiology/Life Sciences

Master’s degree preferred

Job description

Job Purpose

The QC Microbiology Analyst I performs microbiology department related raw material, in-process, and finished product testing according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Must demonstrate a high level of proficiency in Microbiology testing.

Essential Duties And Responsibilities

• Applies quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures.
• Notifies Microbiology management of all OOS and OAL testing results.
• Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information.
• Performs routine testing of products to support release and company needs.
• Trains fellow QC laboratory personnel on QC test methods.
• Demonstrates ability to understand and interpret test results in relation to acceptance or rejection of lot tested.
• Generates data, as needed, for investigations; performs data entry for various systems and processes, and understands the necessity of trending reports
• Reports and initiates documentation and communication of OOS and OOT results and investigation reports.
• Assists the Sample Management team with sample receiving and waste destruction, as needed.
• Performs method validation testing if requested by supervisor.
• Performs general laboratory housekeeping and upkeep of various testing stations.
• Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Shift Lead, QC Microbiology Supervisor, QC Microbiology Operations Manager, Director of Microbiology, or designee.

Supplemental Functions

• Performs other duties as assigned.

Job Specifications And Qualifications

Knowledge & Skills

• 2 – 4 years of experience with Microsoft Office programs, as well as the ability to learn new systems and computer software programs effectively and efficiently required.
• Experience with cGMP documentation systems and with implementation of quality control systems.
• Strong interpersonal, verbal, and written communication skills; effectively multi-tasking and problem solving skills.
• Must maintain flexibility in the assignments of tasks, and be open to receive and provide training in multiple areas.
• Knowledge of FDA manufacturing/regulatory quality systems regulations, qualifications, facilities, and requirements.
• Accepting of new changes in order to achieve department demands.
• Must possess effective written and oral communication skills and be able to handle multiple tasks within limited time frames.
• Aseptic technique and familiarity with cGMPs and regulatory requirements is required.
• Specific expertise, skills and knowledge within microbiology gained through education and experience.
• A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Position requires bending, typing, lifting, reaching, vision, standing (50%), sitting (10%), walking (20%), and hearing.
• Incumbents required to wear safety glasses, gloves, laboratory coats and other non-specified protective equipment as necessary.

Education/Experience

• Regionally accredited Bachelor’s Degree in Biology, Microbiology, or Life Sciences, required; Master’s degree, preferred.
• At least 1-year experience working directly with Pharmaceutical Microbiology methods.
• 1 – 2 years of experience in general laboratory skills and a knowledge of aseptic technique.

Working Conditions / Physical Requirements

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
• Hours of work: 12-hour rotating shifts.
• Salary range: Based on experience.