Job description
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 Tech Services - Microbiology Specialist, located in our Oklahoma City, OK facility.
Area of Responsibilities
Research the viability of potential process changes with regards to endotoxin/bioburden impact and summarize research findings in written reports- Prepares developmental, validation and qualification study protocols and reports
- Performs any necessary laboratory testing to support the execution of Tech Services protocols and projects
- Give technical presentation as required
- Familiar with relevant manufacturing, QA, and QC procedures and practices
- Participate in multi-site project teams to achieve project goals
- Create Tech Services SOPs and revise as necessary
- Calibration, maintenance and operation of lab instrumentation
- Working with vendor for oversight of qualification of equipment/computers
- Standard and sample solution preparation
- Documentation of laboratory work using laboratory worksheets/notebooks; documentation must be detailed, accurate and meet cGMP requirements
- Equipment and computer validation oversight
- Other duties may be assigned
Competences
Competences required to fulfil the area of responsibilities and work assignments:
Education:
- BS/BA degree in in life sciences, biology or related field
Experience:
- 2 – 3 years of experience in Pharmaceutical or similar industry as a Microbiologist (QC/Analytical)
- Proficient in control documentation practices such as Change Control and Deviations
- Technical writing (reports/protocols)
- Computer systems understanding; regarding controlling software for instrumentation
- Prior project management experience a plus
- Analytical instrumentation operation a plus, such as Biotek plate reader
- Analytical instrumentation/method development experience a plus
- 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 scheduling and time management skills
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
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