What are the responsibilities and job description for the QA Microbiologist position at THE RITEDOSE CORPORATION?
Job Details
Description
The QA Microbiologist is responsible for leading/performing activities necessary for implementation of Microbiology Support of product commercialization/technical transfer. These activities include guidance and review of method validations/ transfers, implementation of new methodology, provide training to Microbiology Staff and provide troubleshooting for methods utilized in Microbiology. In addition to these responsibilities, the QA Microbiologist will assist in conducting/reviewing lab investigations, and document reviews and updates.
Responsibilities:
- Provide oversight for transfer/commercialization projects for Microbiology. Responsible for reviewing microbiology method summary reports.
- Assist in writing and revising laboratory SOPs, method validation/transfer protocols and summary reports.
- Responsible for assisting Microbiology with lab investigations, reviewing deviations and ensuring timely closure to meet deadlines and product release dates.
- Perform trending and write or review summary reports as needed.
- Assist with implementation of contamination control planning and maintenance.
- Assist with CAPA creation, review and closure.
- Responsible for performing any special projects as assigned to include timely completion.
- Perform training when needed to staff regarding Microbiology activities.
- Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
Qualifications:
- BS degree in Biology or Microbiology with a minimum of 4 years of experience in a pharmaceutical laboratory or an advanced degree with 2 years of experience in a pharmaceutical laboratory.
- Proficient with current word processing, spreadsheets, and database software.
- Knowledge of operational processes and controls in sterile pharmaceutical manufacturing
- Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships with other departments.
- Ability to think strategically and be detail-oriented
Qualifications
Salary : $60,000 - $70,000