Senior Microbiologist

LanceSoft, Inc.; Sandy (UT); On-site; USD 60,000 - 90,000; Full time

Job summary

LanceSoft, Inc. is seeking a microbiology professional in Sandy, UT to perform and review microbiological assessments of raw materials and finished goods. The role reports to Quality Assurance and emphasizes technical writing to support risk assessment and quality evaluation.

Responsibilities include trend analysis, method development/support, and ensuring compliance with GMP/GDP practices. Onsite role with core hours 8 am–5 pm, Monday to Friday in Sandy, UT.

Qualifications

• BS in Microbiology, Biology, or Biochemistry (or equivalent experience).
• 21 CFR Part 210/211 knowledge and compliance.
• Investigation writing experience.
• Knowledge of microbiological risk assessment processes.
• Experience in pharmaceutical/drug manufacturing environments.
• Technical review and documentation practices.

Responsibilities

• Perform and review microbiological assessments of raw materials and finished goods.
• Prepare technical writing to support risk assessment and quality evaluation.
• Support QA goals with preparation, calibration, and documentation.
• Work independently or on special projects as required.
• Understand and apply microbiological compendial publications.

Skills

Investigation writing

Microbiological Risk Assessment

Technical Review

Pharmaceutical/Drug Manufacturing

Education

BS in Microbiology, Biology, or Biochemistry (or equivalent experience)

Job description

Location: Sandy, UT 84070

Core Hours will be between 8 am – 5 pm Monday – Friday

Onsite Role

TECHNICAL SKILLS

Must Have

• 21 CFR Part 210/211
• BS in Microbiology, Biology, or Biochemistry (or equivalent experience)
• Investigation writing
• Microbiological Risk Assessment
• Pharmaceutical/Drug Manufacturing
• Technical Review

Job Description:

Job Summary:

• Microbiology professional reporting to Quality Assurance by performing and reviewing a broad range of analytical microbiological assessments of moderate complexity on raw materials and finished goods.
• Technical writing to support risk assessment and Quality evaluation.
• Supports these activities with the necessary preparation, quality assurance, calibration and documentation.
• Works independently or co-operatively on special projects as required.
• Understanding of microbiological compendial publications.

Job Responsibilities:

• Microbial trending, assessment and analysis of reported results from finished goods, intermediates, and raw materials.
• Evaluates and reviews microbial and particulate testing to support environmental monitoring program.
• Assist in the development, validation, and remediation of test methods.
• Preparation of various microbiological technical reports.
• As a microbiological SME, conducts documentation review, approval, and researches/evaluates emergent regulatory/compendial standards to ensure compliance.
• Create and execute protocols, risk assessments, reports and/or other technical documents to support laboratory and Quality goals.
• Assist with technical writing, review, and assessment tasks for project and CAPA completion.
• Communicate with leadership and Quality Control/Assurance on product or project status.
• Ensures tasks and projects are completed in a timely manner, with minimal supervision.
• Operates independently with a strategic and self starter mindset.
• Responsible for direct CAPA completion and summary write up in support of audit preparation.
• Authors or updates controlled documents utilizing site change control processes.
• Ensures testing and documentation are performed according to GMP and GDP practices.
• Trend analysis of acceptable and OOS results in support of reports, risk assessments and audit preparation.
• Participate in document reviews and assessment to support alignment with corporate policies.
• Comply with all local, state, federal, and Client safety regulations, policies, and procedures including RCRA Hazardous waste regulations.