Job Overview:
The QC Micro Compliance position is responsible for review of QC-Microbiology data and associated documentation to ensure compliance with company policies, procedures, and specifications as well as with local, state, federal, and international (e.g., EU, Chinese, Japanese) regulations as applicable.
Duties/Responsibilities:
- Review Microbiology testing data, including but not limited to the following testing:
- Endotoxin
- Sterility
- Microbial Enumeration
- Specified Microorganisms
- Bioburden
- Particulate Matter
- Environmental and Personnel Monitoring
- Water testing
- Data review of multiple sample types, including but not limited to:
- Raw material, including APIs and excipients
- Stability
- Finished product / drug product
- In Process
- Clinical material
- Packaging Components
- Data review for appropriate phases:
- Clinical Phases I, II, and III for NDA, ANDA
- Commercial Products
- Author, review, and support for validation protocols, reports, and associated data:
- Microbiology method verification / validation
- Equipment qualification
- Aseptic process simulation
- Research and Development, as required
- Review the data for compliance with cGMP and GDP, including ALCOA+
- Ensure compliance of testing with laboratory procedures, forms, test methods, and protocols
- Educate Microbiologists to improve data reporting, including adherence to GDP and cGMP
- Write and / or support deviations and out of specification investigations
- Adhere to EHS procedures and associated plans
- Perform and / or assist in tracking and reporting status of tasks for associated timelines
- Perform other duties as assigned
Qualifications:
- Bachelor’s degree or higher in Microbiology, Biology, or other Science, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities
- Minimum of 5 years of relevant work experience in Microbiology or data review of Microbiology in the pharmaceutical industry
- Experience in CMO / CDMO, clinical and commercial products is preferred
- Solid understanding of the current federal and international regulations regarding the production, testing, and release of drug products
- Must be able to comprehend and follow all applicable SOPs
- Established experience in reviewing microbiology data for aseptic processing, including product testing and environmental monitoring
- Appropriate technical knowledge necessary to analyze data and make sound decisions on developing issues with minimal supervision
- Proven track record troubleshooting non-conformances and out-of-specification test results
- Strong attention to detail with the ability to manage multiple priorities
- Ability to effectively train others on Microbiology procedures, tests, and techniques
- Clear communication with cross-functional team members with the ability to effect change
- Demonstrated ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates
- Working knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise
- Proficiency with Microsoft programs such as Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Proven ability to complete tasks accurately and according to established and shifting timelines
- Ability to work closely with a diverse customer and employee base (internally and externally)
- Creative, open-minded, and fosters an environment in which sharing of ideas is encouraged
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure, entrepreneurial environment
- Must maintain the appropriate level of integrity and professionalism
- Must communicate fluently in English and have legible handwriting
Physical Demands:
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines when necessary
- Ability to lift up to 40 pounds on occasion
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc.) when necessary
All job requirements in the job description provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
30 To 35 (USD) Hourly
