Jubilant Pharma Limited
EM Compliance Scientist II
Jubilant Pharma Limited, Spokane, Washington, United States, 99254
Overview
The EM Compliance Scientist II is responsible for the overall regulatory compliance, equipment and software qualification, repair and maintenance. This is an on-site, full-time position located in Spokane, WA with Jubilant HollisterStier LLC. Responsibilities
Perform EM Risk Assessment and Summary Reports Perform EMPQs and Summary Reports Perform preventative maintenance and qualification activities on EM software and instrumentation as directed. Implement appropriate computer operating system permissions to laboratory equipment in order to comply with regulatory requirements. Diagnose EM 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 EM software or 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 EM 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 EM compliance and equipment qualifications. Qualifications
Associates of Science with an emphasis in Chemistry, Biology, or related hard science required. Any emphasis in a computer related systems desired. Bachelors of Science desired. 2 years related experience in lieu of hard science emphasis; degree still required. Minimum 2 years related experience required. FDA Regulated Industry and a minimum of 3 years of Laboratory Experience required. Proficiency in troubleshooting instruments and/or mechanical aptitude desired. Proficiency in Microsoft Operating systems and a general understanding of software and database configuration desired. Ability to utilize Microsoft Word and Excel effectively required. Manual Dexterity required. Physical Requirements: Lift up to 25 lbs unassisted. 20/30 corrected near-point vision. Prolonged sitting/standing and repetitive activity. Exposure to allergens. Shift
Weekday Days Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Pharmaceutical Manufacturing Compensation & Benefits
This is an on-site, full-time position located in Spokane, WA. Hiring Wage: $30.93-$41.85/hr, depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role Role follows the ABU holiday schedule Medical, Dental, Vision, Flex 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 Equal Employment Opportunity
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require assistance applying for a position, please contact our HR Department at: JHS-TalentAcquisition@jubl.com
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The EM Compliance Scientist II is responsible for the overall regulatory compliance, equipment and software qualification, repair and maintenance. This is an on-site, full-time position located in Spokane, WA with Jubilant HollisterStier LLC. Responsibilities
Perform EM Risk Assessment and Summary Reports Perform EMPQs and Summary Reports Perform preventative maintenance and qualification activities on EM software and instrumentation as directed. Implement appropriate computer operating system permissions to laboratory equipment in order to comply with regulatory requirements. Diagnose EM 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 EM software or 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 EM 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 EM compliance and equipment qualifications. Qualifications
Associates of Science with an emphasis in Chemistry, Biology, or related hard science required. Any emphasis in a computer related systems desired. Bachelors of Science desired. 2 years related experience in lieu of hard science emphasis; degree still required. Minimum 2 years related experience required. FDA Regulated Industry and a minimum of 3 years of Laboratory Experience required. Proficiency in troubleshooting instruments and/or mechanical aptitude desired. Proficiency in Microsoft Operating systems and a general understanding of software and database configuration desired. Ability to utilize Microsoft Word and Excel effectively required. Manual Dexterity required. Physical Requirements: Lift up to 25 lbs unassisted. 20/30 corrected near-point vision. Prolonged sitting/standing and repetitive activity. Exposure to allergens. Shift
Weekday Days Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Pharmaceutical Manufacturing Compensation & Benefits
This is an on-site, full-time position located in Spokane, WA. Hiring Wage: $30.93-$41.85/hr, depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role Role follows the ABU holiday schedule Medical, Dental, Vision, Flex 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 Equal Employment Opportunity
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require assistance applying for a position, please contact our HR Department at: JHS-TalentAcquisition@jubl.com
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