Quality Assurance Batch Specialist

16 hours ago

Fishers, United States INCOG BioPharma Services Full time

QA Batch Review Specialist


INCOG Biopharma Services in Indianapolis, IN is hiring an QA Batch Review Specialist. They are seeking a highly motivated individual and detail-oriented who will oversee review processes for Manufacturing Batch Record lifecycle activities, including Formulation, Filling, Inspection, Labeling and Packaging, and final-stage review and disposition at a new state-of-art contract development and manufacturing organization.


Working closely with the QA Manager, the QA Specialist – Batch Review will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The successful individual will, at all times, provide support with identifying and closing Operational and Quality gaps.


The QA Batch Review Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. They will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. They will also thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. QA Batch Review Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.


There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.


At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.


Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, INCOG’s clients, and patients.


Job Functions:


  • Independently manage day to day projects and/or team activities and issues on global projects across multiple organizations, geographies, and business areas.
  • Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
  • Provide Client access and support in the review, approval of Batch Records and training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
  • Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
  • Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
  • Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
  • Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
  • Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.


Candidate Requirements:


  • Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
  • 4 years minimum experience working in a GMP environment.
  • 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).


Additional Preferences:


  • 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.
  • 2 years’ experience with assessment and review of Quality Control testing, CoA, and results management preferred.
  • Extensive knowledge of regulations and quality processes involving product disposition.


Why INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations


Don’t meet all the requirements? Don’t sweat We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…


Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

  • Senior Quality Assurance Specialist

    16 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Senior Quality Assurance Specialist INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Quality Assurance Specialist. They are looking for a Senior Quality Assurance Specialist specializing in Technical Operations who will support oversight of technical operations with review of Technical Transfer documents, Master Batch Records, client specific...

  • Senior Quality Assurance Specialist

    11 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Senior Quality Assurance Specialist INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Quality Assurance Specialist. They are looking for a Senior Quality Assurance Specialist specializing in Technical Operations who will support oversight of technical operations with review of Technical Transfer documents, Master Batch Records, client specific...

  • Quality Assurance Specialist

    3 weeks ago

    Fishers, United States ROI Search Group Full time

    Job DescriptionJob DescriptionWe are seeking a Quality Assurance Specialist to join a Fishers, IN, manufacturing organization providing world-class systems, processes, and services for the Pharmaceutical and Healthcare industry. This position is full-time and 100% on-site in Fishers five days per week and operates in a 24/7 environment. Therefore, the...

  • Quality Assurance Specialist

    3 days ago

    Fishers, United States ROI Search Group Full time

    Job DescriptionJob DescriptionWe are seeking a Quality Assurance Specialist to join a Fishers, IN, manufacturing organization providing world-class systems, processes, and services for the Pharmaceutical and Healthcare industry. This position is full-time and 100% on-site in Fishers five days per week and operates in a 24/7 environment. Therefore, the...

  • Head of Quality Assurance

    3 weeks ago

    Fishers, Indiana, United States INCOG BioPharma Services Full time

    Quality Assurance ExecutiveINCOG BioPharma Services is seeking a dedicated Quality Assurance Executive who possesses a strong commitment to guiding teams and refining processes. This role is essential in our mission to develop critical pharmaceutical products while working within a highly regarded organization.Key ResponsibilitiesDirect the strategic vision...

  • Head of Quality Assurance

    3 weeks ago

    Fishers, Indiana, United States INCOG BioPharma Services Full time

    Quality Assurance ExecutiveINCOG BioPharma Services is seeking a dedicated Quality Assurance Executive who possesses a strong commitment to guiding teams and enhancing processes. This role is crucial for the advancement of innovative therapeutic solutions within a reputable organization.Key ResponsibilitiesDirect the strategic vision and operational...

  • Head of Quality Assurance

    3 weeks ago

    Fishers, Indiana, United States INCOG BioPharma Services Full time

    Quality Assurance ExecutiveINCOG BioPharma Services is seeking a dedicated Quality Assurance Executive who excels in guiding teams and enhancing processes, with a strong foundation in various leadership methodologies. This role offers the chance to impact the development of critical pharmaceutical products within a respected organization.Key...

  • Director of Quality Assurance

    4 weeks ago

    Fishers, United States INCOG BioPharma Services Full time

    DescriptionWe are seeking a Director of Quality Assurance that has a passion for leading people and processes, and is familiar with transformational, situational, and servant leadership concepts. The Director will support continuous personal and professional development of QA staff through meaningful goal setting, performance management, and career...

  • Quality Assurance Compliance Specialist

    16 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Quality Assurance Compliance SpecialistINCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Compliance Specialist. They are seeking a highly motivated individual and detail-oriented who will help with implementing Quality procedures and standards throughout the stages of drug product manufacturing, packaging, and release. Working...

  • Quality Assurance Compliance Specialist

    12 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Quality Assurance Compliance SpecialistINCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Compliance Specialist. They are seeking a highly motivated individual and detail-oriented who will help with implementing Quality procedures and standards throughout the stages of drug product manufacturing, packaging, and release. Working...

  • Software Quality Assurance Specialist

    1 week ago

    Fishers, Indiana, United States Johnson Controls International Full time

    Software Engineering Internship OpportunityJohnson Controls International invites you to apply for an internship located in Fishers, Indiana. This internship is designed to provide you with a positive work/training experience and challenging objectives.Key Responsibilities:Work as a team member in the software engineering departmentContribute to the...

  • Quality Assurance Analyst

    3 weeks ago

    Fishers, Indiana, United States Maxonic Full time

    Job OverviewMaxonic is seeking a dedicated Quality Assurance Analyst to support our client, Thermo Fisher Scientific.Compensation: $30 per hourContract Duration: 12 monthsKey Responsibilities:Establishing and overseeing quality management processes for patient testing, including pre-analytical, analytical, and post-analytical phases.Conducting regular audits...

  • Quality Assurance Engineer

    2 days ago

    Fishers, Indiana, United States Verista Full time

    {"title": "Job Description", "content": "Job SummaryVerista is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services, and for implementing and maintaining our quality management system.Key Responsibilities:Manage and work...

  • Traveling Specialist

    3 weeks ago

    Fishers, United States Stratosphere Quality Part time $19 - $20

    Job DescriptionJob DescriptionOverviewSUMMARY OF RESPONSIBILITIESResponsible for coordinating the company's travel needsPart Time Traveling Specialist includes weekends/on-call - Remote Pay rate: $19 - $20 phTop 10 Reasons to work for Stratosphere Quality:Vacation TimeStart accruing PTO on Day OneBenefitsMedical Benefits, Life Insurance, & 401k all after...

  • Quality Validation Specialist

    16 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Quality Validation Specialist INCOG BioPharma is looking for a Quality Validation Specialist to join their QA team! This individual will be working closely with the Manager of QA and will be instrumental in ensuring site compliance with regulations, industry standards (ISPE, PDA, ASTM, etc), and organizational SOPs. The Quality Validation Specialist will...

  • Quality Validation Specialist

    11 hours ago

    Fishers, United States INCOG BioPharma Services Full time

    Quality Validation Specialist INCOG BioPharma is looking for a Quality Validation Specialist to join their QA team! This individual will be working closely with the Manager of QA and will be instrumental in ensuring site compliance with regulations, industry standards (ISPE, PDA, ASTM, etc), and organizational SOPs. The Quality Validation Specialist will...

  • Quality Assurance Development Intern

    4 days ago

    Fishers, Indiana, United States Johnson Controls International Full time

    Software Engineering Internship OpportunityJohnson Controls invites you to apply for an internship located in Fishers, Indiana.This internship is designed to provide you with a positive work/training experience and challenging objectives.As a member of the software engineering team, you will work as a team to develop and test software applications.Key...

  • Produce Quality Control Specialist

    2 weeks ago

    Fishers, Indiana, United States US Foods, Inc. Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Produce Quality Control Specialist to join our team at US Foods, Inc. As a key member of our operations team, you will play a critical role in ensuring the quality of our fresh produce products.Key ResponsibilitiesInspect and Evaluate Fresh Produce: Conduct daily inspections of all incoming fresh...

  • Quality Control Technician, Bulk Syringe

    3 weeks ago

    Fishers, United States Stevanato Group Full time

    The Quality Control Technician, Bulk Syringe has dual responsibility to support the Quality Line Reference Technicians regarding defect identification, and for data analysis and metrics collection of related QLR cosmetic and dimensional checks. Additionally, they are responsible for documentation review of batch records prior to quality control release of...

  • Quality Control Technician, Bulk Syringe

    1 month ago

    Fishers, United States Stevanato Group Full time

    The Quality Control Technician, Bulk Syringe has dual responsibility to support the Quality Line Reference Technicians regarding defect identification, and for data analysis and metrics collection of related QLR cosmetic and dimensional checks. Additionally, they are responsible for documentation review of batch records prior to quality control release of...