Verista
Senior Quality Specialist - 5047
Verista, Boston, Massachusetts, us, 02298
Verista’s
600 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 Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseResponsibilities:As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to site Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operationsResponsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.Responsible for review and approval of COAs, and product releaseProvide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.Review and approval of manufacturing documents.Develop and deliver technical training programsSupports drafting and revising Quality Agreements between CMOs/Suppliers and site, as neededProvide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.Provides experienced technical advice for fill finish related program decisionsProvides project support involving technical transfers, engineering projects and similar activitiesParticipate in compliance walkthroughs and help drive the closure of any observationsResponsible for identifying risks and communicating gaps for GMP process/systemsResponsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.Participate in continuous improvements of department processes.Participate in inspection readiness and support activitiesParticipate in process improvement initiatives (as necessary).Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely mannerExperience on product complaints investigations and recallsQualifications:Demonstrated success by independently leading cross-functional teamsExperience providing QA support and oversight of GMP manufacturing operation including batch releaseExperience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:Cell and gene therapy cGMP’s and associated CMC regulatory considerationsAseptic processingExperience successfully leading event investigations, Root Cause Analysis and CAPAExperience with network-based applications such as Oracle, TrackWiseMaster’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.Why Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at
Verista.comFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
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600 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 Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseResponsibilities:As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to site Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operationsResponsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.Responsible for review and approval of COAs, and product releaseProvide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.Review and approval of manufacturing documents.Develop and deliver technical training programsSupports drafting and revising Quality Agreements between CMOs/Suppliers and site, as neededProvide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.Provides experienced technical advice for fill finish related program decisionsProvides project support involving technical transfers, engineering projects and similar activitiesParticipate in compliance walkthroughs and help drive the closure of any observationsResponsible for identifying risks and communicating gaps for GMP process/systemsResponsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.Participate in continuous improvements of department processes.Participate in inspection readiness and support activitiesParticipate in process improvement initiatives (as necessary).Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely mannerExperience on product complaints investigations and recallsQualifications:Demonstrated success by independently leading cross-functional teamsExperience providing QA support and oversight of GMP manufacturing operation including batch releaseExperience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:Cell and gene therapy cGMP’s and associated CMC regulatory considerationsAseptic processingExperience successfully leading event investigations, Root Cause Analysis and CAPAExperience with network-based applications such as Oracle, TrackWiseMaster’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.Why Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at
Verista.comFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
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