Onsite Temporary (3-month) contract

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

Manager's Update:
 

Minimum educational qualification: BS Degree in Microbiology/Biology/Biochemistry

• Manager is looking for 5+ years of exp.
• This person would be involving in remediation projects and in microbiology
• Must have prior microbiology background
• Must have prior technical writing and investigation skills
• Must have CAPA investigation exp.
• Drug regulation exp. is required
• Able to write risk assessments
• Typical microbiology testing is not required
• Manager is fine with MS/PhD degree as well
• Must have prior industry exp. is required
• Microbiology background is a hard requirement in this role
• Prior pharma exp. is preferred but other regulated industry exp. is also considerable
• This is not a bench based or laboratory based role. This person may go within the lab for some observation but not involving in any lab work

Must Have:

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

JOB DESCRIPTION

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.

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