Alkermes
QC Analyst I-Environmental Monitoring - 3rd Shift
Alkermes, Wilmington, Ohio, United States, 45177
POSITION SUMMARY
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.
MAJOR RESPONSIBILITIES
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 overtime, weekend, shift work, and holidays (40%).
Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) (35%).
Enumerate organisms on cultured media for environmental monitoring and utility samples (15%).
Review routine paperwork (5%).
Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans (10%).
QUALIFICATIONS
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.
EDUCATION AND EXPERIENCE
Education: High school diploma, Associate or Bachelor Degree in a biological science.
Experience: High school diploma with some experience in a GMP lab environment or Bachelor or Associate Degree in a biological science. Some college education may be substituted with additional years of relevant work experience.
WORKING CONDITIONS
The employee should have the ability to function in a microbiological laboratory and manufacturing environment, with no health conditions or allergies that would prevent them from safely handling microorganisms or aseptically gowning. Aseptic gowning must be able to be maintained including an annual requalification.
Employee must be able to pass a vision exam prior to employment and annually thereafter.
The employee will be required to participate in an on-call schedule for various shift, holiday, or weekend work as needed.
PHYSICAL REQUIREMENTS
Prolonged periods of sitting or standing.
Occasional periods of repetitive motion.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed.
Makeup and jewelry will not be permitted for work in classified areas or other areas as necessary.
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MAJOR RESPONSIBILITIES
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 overtime, weekend, shift work, and holidays (40%).
Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) (35%).
Enumerate organisms on cultured media for environmental monitoring and utility samples (15%).
Review routine paperwork (5%).
Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans (10%).
QUALIFICATIONS
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.
EDUCATION AND EXPERIENCE
Education: High school diploma, Associate or Bachelor Degree in a biological science.
Experience: High school diploma with some experience in a GMP lab environment or Bachelor or Associate Degree in a biological science. Some college education may be substituted with additional years of relevant work experience.
WORKING CONDITIONS
The employee should have the ability to function in a microbiological laboratory and manufacturing environment, with no health conditions or allergies that would prevent them from safely handling microorganisms or aseptically gowning. Aseptic gowning must be able to be maintained including an annual requalification.
Employee must be able to pass a vision exam prior to employment and annually thereafter.
The employee will be required to participate in an on-call schedule for various shift, holiday, or weekend work as needed.
PHYSICAL REQUIREMENTS
Prolonged periods of sitting or standing.
Occasional periods of repetitive motion.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed.
Makeup and jewelry will not be permitted for work in classified areas or other areas as necessary.
#LI-RS1
#Onsite
#J-18808-Ljbffr