Verista, Inc.
5909 - GMP Quality Auditor / Senior Quality Specialist
Verista, Inc., Boston, Massachusetts, us, 02298
Overview 5909 - GMP Quality Auditor / Senior Quality Specialist
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration. Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company culture & values
We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged We constantly acquire new skills and learn from our experiences to enhance our collective expertise Role and responsibilities
Support quality oversight for root-cause analysis and product impact assessments Ensure appropriate CAPA actions are identified for deviations, OOS, and OOT investigations Support change control assessments, implementation, and closure Identify and facilitate continuous improvement efforts Support drafting and revising Quality Agreements between CMOs/Suppliers and client Support cross-functional working teams, applying strong communication and collaboration skills Perform review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data) Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods Support GMP document review, including certificate of analysis, specifications Requirements
Bachelor's Degree in industry-related field 3+ years of Operational QA experience in analytical or manufacturing setting Experience in small molecule manufacturing - additional experience with biologics, devices, gene therapy a plus Experience supporting cross-functional projects/teams within stated objectives and timelines Good communication skills (written and verbal) and the ability to exchange potentially complex information Able to integrate activities with other groups, departments and project teams as needed Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives Expanded conceptual knowledge of cGMP's in a pharmaceutical setting Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA Practical GxP knowledge and understanding across lifecycle of the product Salary & location National (US) Range: $70,491 - $99,899 USD Why Verista?
High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Equal Employment Opportunity Verista is an equal opportunity employer.
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Be one of the first applicants, read the complete overview of the role below, then send your application for consideration. Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company culture & values
We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged We constantly acquire new skills and learn from our experiences to enhance our collective expertise Role and responsibilities
Support quality oversight for root-cause analysis and product impact assessments Ensure appropriate CAPA actions are identified for deviations, OOS, and OOT investigations Support change control assessments, implementation, and closure Identify and facilitate continuous improvement efforts Support drafting and revising Quality Agreements between CMOs/Suppliers and client Support cross-functional working teams, applying strong communication and collaboration skills Perform review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data) Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods Support GMP document review, including certificate of analysis, specifications Requirements
Bachelor's Degree in industry-related field 3+ years of Operational QA experience in analytical or manufacturing setting Experience in small molecule manufacturing - additional experience with biologics, devices, gene therapy a plus Experience supporting cross-functional projects/teams within stated objectives and timelines Good communication skills (written and verbal) and the ability to exchange potentially complex information Able to integrate activities with other groups, departments and project teams as needed Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives Expanded conceptual knowledge of cGMP's in a pharmaceutical setting Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA Practical GxP knowledge and understanding across lifecycle of the product Salary & location National (US) Range: $70,491 - $99,899 USD Why Verista?
High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Equal Employment Opportunity Verista is an equal opportunity employer.
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