Jubilant HollisterStier CMO
Quality Assurance Compliance Specialist/Sr. Specialist
Jubilant HollisterStier CMO, San Francisco, California, United States, 94199
Quality Assurance Compliance Specialist/Sr. Specialist
Join to apply for the
Quality Assurance Compliance Specialist/Sr. Specialist
role at
Jubilant HollisterStier CMO Quality Assurance Compliance Specialist/Sr. Specialist
Join to apply for the
Quality Assurance Compliance Specialist/Sr. Specialist
role at
Jubilant HollisterStier CMO Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Jubilant HollisterStier CMO POSITION LOCATED AT OUR SPOKANE, WA- RELOCATION OFFERED 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. Job Description: The QA Compliance Associate/Sr. Associate
provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. 1. Lead, facilitate, and conduct deviations, non-conformances investigations. 2. Author/draft investigation reports with minimal guidance. 3. Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. 4. Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact. 5. Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP. 6. Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance. 7. Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors. 8. Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends. 9. Work with cross functional team member(s) to develop appropriate CAPA actions. 10. Ensure investigations, corrections and CAPA are generated and approved in a timely manner. 11. Act as liaison as it relates to specific investigations during client calls and audits. 12. Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms. 13. Communicate/Escalate to management any issues or delays identified during the investigation process. 10. Special assignments as directed by the supervisor. Sr. Associate: (In addition to above) 1. Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company. 2. Speak to assigned deviations during regulatory and client audits. 3. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate) Qualifications: Associate: Associates Degree in Biology, Chemistry or related field required. 5 years of experience may be used in a lieu of an Associate’s degree. Bachelor’s Degree in a science field desired. Sologic Certificate Minimum 2 years of experience required. 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 bio/pharma industry desired. Knowledge of cGMPs desired. Basic exchange of information required. Managing conflict and influencing outcomes desired. Provides analysis, diagnosis or production tasks which noticeably impact end results. Sr. Associate: Associates Degree in Biology, Chemistry or related field required. Minimum of 5 years related experience required with an Associate’s Degree. Minimum of 2 years related experience required with a Bachelor degree. Pharmaceutical and FDA Regulated Experience required. Microsoft Word/ Excel and knowledge of cGMPs required. Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required. Must have ability to prioritize investigations based on impact to the facility and release of batches. Bachelor’s Degree in a science field desired. Direct or supporting aseptic manufacturing experience in bio/pharma industry desired. Shift:
Weekday Days – 8:00am - 4:30pm Compensation: This is an
on-site,
full-time position located in Spokane, WA. Hiring Wage: Associate: $30.01 - $35.30 Sr. Associate: $77,698.80 - $101,200 depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package. 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 Optional Benefits: Voluntary Life and AD&D for employee & family Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages) Pet Insurance ID Theft Protection Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today! https://jubilantcareer.jubl.com/ *Please click on the Spokane, Wa. Link* 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 Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Jubilant HollisterStier CMO by 2x Sign in to set job alerts for “Quality Assurance Compliance Specialist” roles.
Specialist, Quality Assurance Operations
Alameda, CA $90,000.00-$100,000.00 4 days ago San Mateo, CA $140,000.00-$170,000.00 1 month ago Richmond, CA $66,087.50-$85,525.00 3 days ago Specialist, Inventory Control & Quality Assurance
San Francisco, CA $28.00-$30.00 5 months ago Hercules, CA $68,640.00-$83,100.00 5 days ago Hercules, CA $75,500.00-$103,900.00 3 days ago San Francisco, CA $26.50-$35.00 1 month ago Redwood City, CA $85,000.00-$110,000.00 2 weeks ago Oakland, CA $120,000.00-$140,000.00 3 weeks ago Foster City, CA $67,699.00-$78,080.00 1 day ago Quality Systems Specialist II, Document Control
Novato, CA $46,996.00-$56,996.00 2 days ago Sr Specialist, Quality Systems Technology (QST)
San Francisco, CA $37.96-$60.64 1 month ago Representative 1, Field Operations - Quality Control
Representative 1, Field Operations - Quality Control-1
San Francisco, CA $48.00-$52.00 9 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Join to apply for the
Quality Assurance Compliance Specialist/Sr. Specialist
role at
Jubilant HollisterStier CMO Quality Assurance Compliance Specialist/Sr. Specialist
Join to apply for the
Quality Assurance Compliance Specialist/Sr. Specialist
role at
Jubilant HollisterStier CMO Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Jubilant HollisterStier CMO POSITION LOCATED AT OUR SPOKANE, WA- RELOCATION OFFERED 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. Job Description: The QA Compliance Associate/Sr. Associate
provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. 1. Lead, facilitate, and conduct deviations, non-conformances investigations. 2. Author/draft investigation reports with minimal guidance. 3. Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. 4. Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact. 5. Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP. 6. Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance. 7. Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors. 8. Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends. 9. Work with cross functional team member(s) to develop appropriate CAPA actions. 10. Ensure investigations, corrections and CAPA are generated and approved in a timely manner. 11. Act as liaison as it relates to specific investigations during client calls and audits. 12. Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms. 13. Communicate/Escalate to management any issues or delays identified during the investigation process. 10. Special assignments as directed by the supervisor. Sr. Associate: (In addition to above) 1. Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company. 2. Speak to assigned deviations during regulatory and client audits. 3. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate) Qualifications: Associate: Associates Degree in Biology, Chemistry or related field required. 5 years of experience may be used in a lieu of an Associate’s degree. Bachelor’s Degree in a science field desired. Sologic Certificate Minimum 2 years of experience required. 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 bio/pharma industry desired. Knowledge of cGMPs desired. Basic exchange of information required. Managing conflict and influencing outcomes desired. Provides analysis, diagnosis or production tasks which noticeably impact end results. Sr. Associate: Associates Degree in Biology, Chemistry or related field required. Minimum of 5 years related experience required with an Associate’s Degree. Minimum of 2 years related experience required with a Bachelor degree. Pharmaceutical and FDA Regulated Experience required. Microsoft Word/ Excel and knowledge of cGMPs required. Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required. Must have ability to prioritize investigations based on impact to the facility and release of batches. Bachelor’s Degree in a science field desired. Direct or supporting aseptic manufacturing experience in bio/pharma industry desired. Shift:
Weekday Days – 8:00am - 4:30pm Compensation: This is an
on-site,
full-time position located in Spokane, WA. Hiring Wage: Associate: $30.01 - $35.30 Sr. Associate: $77,698.80 - $101,200 depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package. 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 Optional Benefits: Voluntary Life and AD&D for employee & family Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages) Pet Insurance ID Theft Protection Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today! https://jubilantcareer.jubl.com/ *Please click on the Spokane, Wa. Link* 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 Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Jubilant HollisterStier CMO by 2x Sign in to set job alerts for “Quality Assurance Compliance Specialist” roles.
Specialist, Quality Assurance Operations
Alameda, CA $90,000.00-$100,000.00 4 days ago San Mateo, CA $140,000.00-$170,000.00 1 month ago Richmond, CA $66,087.50-$85,525.00 3 days ago Specialist, Inventory Control & Quality Assurance
San Francisco, CA $28.00-$30.00 5 months ago Hercules, CA $68,640.00-$83,100.00 5 days ago Hercules, CA $75,500.00-$103,900.00 3 days ago San Francisco, CA $26.50-$35.00 1 month ago Redwood City, CA $85,000.00-$110,000.00 2 weeks ago Oakland, CA $120,000.00-$140,000.00 3 weeks ago Foster City, CA $67,699.00-$78,080.00 1 day ago Quality Systems Specialist II, Document Control
Novato, CA $46,996.00-$56,996.00 2 days ago Sr Specialist, Quality Systems Technology (QST)
San Francisco, CA $37.96-$60.64 1 month ago Representative 1, Field Operations - Quality Control
Representative 1, Field Operations - Quality Control-1
San Francisco, CA $48.00-$52.00 9 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr