Astrix
Overview
The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Responsibilities
Prepare such as change controls, risk assessments, SOPs, protocols, final reports (20%) Perform training of manufacturing and environmental monitoring personnel (20%) Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule may require overtime, 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; promote safe practices and aseptic 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 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 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. Working Conditions
The successful employee will function in a microbiological laboratory and manufacturing environment with safe handling of microorganisms; aseptic gowning required with annual requalification Employee must be able to pass a vision exam prior to employment and annually thereafter On-call schedule for various shift, holiday, or weekend work as needed Physical Requirements
Prolonged periods of sitting or standing Occasional repetitive motion Walking, lifting, pushing and pulling carts, reaching, climbing, and bending Steel toe shoes, scrubs, safety glasses, and other PPE as required Makeup and jewelry restrictions in classified areas or as necessary Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: IT Services and IT Consulting
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The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Responsibilities
Prepare such as change controls, risk assessments, SOPs, protocols, final reports (20%) Perform training of manufacturing and environmental monitoring personnel (20%) Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule may require overtime, 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; promote safe practices and aseptic 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 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 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. Working Conditions
The successful employee will function in a microbiological laboratory and manufacturing environment with safe handling of microorganisms; aseptic gowning required with annual requalification Employee must be able to pass a vision exam prior to employment and annually thereafter On-call schedule for various shift, holiday, or weekend work as needed Physical Requirements
Prolonged periods of sitting or standing Occasional repetitive motion Walking, lifting, pushing and pulling carts, reaching, climbing, and bending Steel toe shoes, scrubs, safety glasses, and other PPE as required Makeup and jewelry restrictions in classified areas or as necessary Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: IT Services and IT Consulting
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