QC Analyst III - Microbiology/EM
Onsite Requirement
100% onsite
Location
Dayton, OH 45177
Position Id
2525
Recruiter Contact
ALLISON
Job Description
The QC Analyst III - Microbiology EM position is a highly experienced analyst position within the QC laboratory. The QC Analyst III performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner. The QC Analyst III requires the least comprehensive in-house training curriculum of any analyst position in the laboratory by virtue of prior experience, although documented proficiency is required for the execution of all activities. The QC Analyst III performs all activities according to approved written procedures. Because of the level of experience associated with this position, a QC Analyst III may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, equipment IQ, OQ, PQ activities, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst III will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of quality control supervisory staff.
MAJOR RESPONSIBILITIES
|
Major Responsibility |
Percentage of time spent on each responsibility |
|
Prepare such as change controls, risk assessments, SOP’s, protocols, final reports |
20% |
|
Perform training of manufacturing and EM personnel |
20% |
|
Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays |
20% |
|
Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) |
20% |
|
Enumerate organisms for environmental monitoring and utility samples. |
10% |
|
Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. |
10% |
QUALIFICATIONS
- Technical writing skills which require minimal guidance from management
- Ability to work hard and contribute to an enjoyable working environment
- Ability to work safely; seek out and encourage safe practices Gowning in an aseptic environment
- Self-starter that takes initiative to perform work with minimal supervision
- Maintain documentation in accordance with GMP including timely recording of information
- Pays attention to detail and ensures high quality work
- Ability to cope with a rapidly changing work environment
- Maintains a clean, organized lab environment
- Commitment to teamwork
- Willingness to learn new things
- Commitment to continuous improvement in all areas
- Effective communication with co-workers and supervisors
- Lead training on environmental monitoring, utilities, gowning, or aseptic practices
- Works closely with manufacturing for training and sample coordination
- Maintain documentation in accordance with GMP including timely recording of information
- Able to come up with solutions and resolve minor issues
- Audit support as needed
EDUCATION AND EXPERIENCE
EDUCATION: Bachelors/Associates in Biology (or related field) or high school diploma with additional experience being substituted for a degree
EXPERIENCE: 6 years of cGMP laboratory and/or Pharmaceutical Quality experience. Some college education may be substituted with additional years of relevant work experience.