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QC Microbiologist
About ALK
ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.
Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port
Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.
ALK has an opening for a full-time QC Microbiologist II located in our Oklahoma City, OK facility.
Area of Responsibilities
- Perform or oversee growth promotion and media release testing.
- Ability to test and identify organisms on Maldi unit.
- Assist and oversee environmental monitoring procedures.
- Assist and oversee microbial water testing.
- Perform, assist or oversee sampling procedures for water for injection system.
- Perform endotoxin testing.
- Perform or oversee component receipt and release and any associated testing.
- Perform, assist, or oversee sterility testing procedures including the reading of sterility results.
- Perform or oversee bioburden testing.
- Perform or oversee trending of environmental monitoring data.
- Perform or oversee testing of biological indicators.
- Review of documentation.
- Perform validations for all Microbiology test methods.
- Perform qualifications on Microbiology Lab equipment.
- Responsible for Microbiology Lab daily operations.
- Responsible to ensure that all QC Microbiology procedures are compliant with guidance and regulations.
- Act as the primary investigator for Microbiology tests.
Competences
Competences required to fulfil the area of responsibilities and work assignments:
Education:
- BS / BA in life sciences, biology, chemistry or related field
Experience:
- This position requires at least one year experience in a laboratory setting.
- Technical writing experience and ability to draft and or write laboratory procedures.
- Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines is required.
- The ideal candidate must be willing to be held accountable and must work well with others in order to ensure that all objectives are met on a regular and timely basis
- Excellent written and verbal communication skills
- Proficient in Microsoft Office applications, particularly Word and Excel
- Excellent laboratory technique and analytical skills
- Excellent scheduling and time management skills with daily operations and special projects.
ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Job Type: Full-time
Pay: $55,000 - $60,000
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
10:00 AM to 6:30 PM Monday - Friday
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