Jubilant Pharma Limited
QA Compliance Associate-Weekdays
Jubilant Pharma Limited, Spokane, Washington, United States, 99254
Apply for the
QA Compliance Associate-Weekdays
role at
Jubilant Pharma Limited .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts used to treat allergies and asthma. The company is a proud member of the Jubilant Pharma family.
Job Description
Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
Accountable for facilitating Deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
Enter data into database to support corporate RCA and CAPA activities.
Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing meeting minutes, and following up on agreed activities and tasks.
Interface with management and responsible individuals to assure task completion on or before established due dates.
Support quality systems, processes and procedures (e.g., Deviations, CAPA, Vendor complaint) to assure compliance and product quality and safety.
Assist QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audits or regulatory inspections.
Provide Deviations and CAPA metrics as needed for management review of system data.
Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Qualifications
Associate’s degree in Biology, Chemistry or related field required.
5 years of experience may be used in lieu of an Associate’s degree.
Bachelor’s degree in a science field desired.
Sologic Certificate desired.
Minimum 2 years of experience required; a Bachelor's degree can be used in lieu of experience.
Pharmaceutical and FDA-regulated industry experience desired.
Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
Direct or supporting aseptic manufacturing experience in the bio/pharma industry desired.
Microsoft Word & Excel experience required.
Knowledge of cGMPs desired.
Shift Weekday Days, Monday – Friday
Compensation & Benefits
Hiring Wage: $30.99 – $41.93 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.
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.
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today.
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
Referrals increase your chances of interviewing at Jubilant Pharma Limited by 2x.
Get notified about new Quality Assurance Associate jobs in
Spokane, WA .
#J-18808-Ljbffr
QA Compliance Associate-Weekdays
role at
Jubilant Pharma Limited .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts used to treat allergies and asthma. The company is a proud member of the Jubilant Pharma family.
Job Description
Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
Accountable for facilitating Deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
Enter data into database to support corporate RCA and CAPA activities.
Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing meeting minutes, and following up on agreed activities and tasks.
Interface with management and responsible individuals to assure task completion on or before established due dates.
Support quality systems, processes and procedures (e.g., Deviations, CAPA, Vendor complaint) to assure compliance and product quality and safety.
Assist QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audits or regulatory inspections.
Provide Deviations and CAPA metrics as needed for management review of system data.
Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Qualifications
Associate’s degree in Biology, Chemistry or related field required.
5 years of experience may be used in lieu of an Associate’s degree.
Bachelor’s degree in a science field desired.
Sologic Certificate desired.
Minimum 2 years of experience required; a Bachelor's degree can be used in lieu of experience.
Pharmaceutical and FDA-regulated industry experience desired.
Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
Direct or supporting aseptic manufacturing experience in the bio/pharma industry desired.
Microsoft Word & Excel experience required.
Knowledge of cGMPs desired.
Shift Weekday Days, Monday – Friday
Compensation & Benefits
Hiring Wage: $30.99 – $41.93 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.
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.
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today.
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
Referrals increase your chances of interviewing at Jubilant Pharma Limited by 2x.
Get notified about new Quality Assurance Associate jobs in
Spokane, WA .
#J-18808-Ljbffr