EM Compliance Scientist II
About The Position
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. Our Promise: Caring, Sharing, Growing We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources. The EM Compliance Scientist II is responsible for the qualification, repair, maintenance and compliance of laboratory instruments and software.
Requirements
- Associates Degree of Science with minimum 2 years of experience required
- 2 to 4 years related experience required
- Microsoft Word and Microsoft Excel experience required
- Mechanical Aptitude required
- Manual Dexterity required
- Knowledge, practical application, and understanding of analytical instrumentation is necessary to perform the functions of this position. The incumbent must have an ability to utilize scientific and or technical literature, and to make effective written and oral reports that are clear, accurate, and logical. A working knowledge of chemistry, statistics, computer-assisted data processing, and good-manufacturing practices is desirable. Must demonstrate initiative and a willingness to learn.
- Ability to lift 25 pounds unassisted required
- Exposure to Allergens required
- Repetitive Activity, prolonged sitting and standing required
Nice To Haves
- Bachelor's Degree of Science Major(s): Chemistry, Biology, or related hard science desired
- Pharmaceutical and FDA Regulated Industry Experience desired
- Laboratory Experience (3 years) desired
- Proficiency in troubleshooting instruments and/or a mechanical aptitude desired
- Proficiency with Microsoft Operating systems as well as general understanding of software and database configuration desired
- Experience with data visualization software/coding languages desired
- Specific Coursework: Any emphasis in computer related systems desired
Responsibilities
- Perform preventative maintenance and qualification activities on laboratory instrumentation as directed.
- Implement appropriate computer operating system permissions to laboratory equipment workstations in order to comply with regulatory requirements.
- Diagnose laboratory equipment issues and perform the necessary maintenance to return equipment to a compliant functionality. Assist in other forms of troubleshooting as directed by the Supervisor.
- Prepare acceptance reports for laboratory equipment.
- Complete core training per procedures.
- Adhere to the pertinent aspects of plant safety programs and in keeping with GMP's or other regulations.
- Maintain and operate laboratory equipment to assure accuracy and confidence in performance.
- Perform computer systems backup as required and ensure data integrity is maintained.
- Create new procedures as needed.
- Participate in direct internal and/or external client interactions.
- Perform special assignments as directed by Supervisor.
- Coordinate and lead group projects related to laboratory compliance and equipment.
Benefits
- Role follows the ABU holiday schedule
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
1,001-5,000 employees
