Software Specialist Jobs in Durham, NC

As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.

You will partner directly with the QC department to provide day-to-day quality compliance support, serving as a trusted gatekeeper for data integrity, support investigations and manage change controls related to laboratory systems, test methods, and digital applications, ensuring modifications do not compromise the validated state of our operations.

This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.

When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.
  • Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.

li>Technical: Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise) Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable).

The QA Specialist, EMQO supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision.

p style="font-size:11pt;line-height:116%;margin:0pt">Abrigo is seeking an IT Assurance Specialist to join our IT Risk & Assurance Team, assisting with recurring IT internal control testing, third-party risk management activities, and audit and compliance operations for a fintech SaaS company serving community financial institutions nationwide.

What You’ll Need:

• Degree in Information Systems, Cybersecurity, Accounting, Computer Science, Business Administration, or related discipline; equivalent professional experience or relevant internships may be considered in lieu of a degree.

Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.

Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.

For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.

li>Perform all daily inspection and test of the scope and character necessary to achieve the quality of electrical construction required in the drawings and specifications for all works under the contract performed ON or OFF site.

All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Responsibilities include: preparing and providing technical quality control for environmental documents and permit applications developing and executing dispersion modeling approaches and protocols preparing emissions inventories, health risk evaluations (as applicable), and compliance analyses mentoring staff and coordinating and reviewing technical work across project phases developing task scopes, budgets, and schedules, and supporting proposal and marketing efforts when requested helping project managers to integrate air quality strategy into broader project planning and environmental compliance frameworks, including beginning to advise project teams and clients on regulatory interpretation and risk considerations and serving as a technical resource where appropriate in client and agency interactions. A senior-level environmental planner at Anchor QEA can expect: Strategic, impact-focused role, shaping project approaches and outcomes Highly supportive environment as part of multi-disciplinary, collaborative teams Opportunities for client and agency interaction, helping to guide key decision makers Contribution to business development strategies emphasizing valued relationships Strong emphasis on professional development for technical and leadership growth Culture of flexibility and accountability with an emphasis on work-life balance.

p>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus.

This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to:

• Executed Batch record review and approval.

This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to:

• Executed Batch record review and approval.

p>Job Responsibilities:

• Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.

  Minimum Requirements:

  • Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

p>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus.

Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions.

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Job Responsibilities:

• Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.

  Minimum Requirements:

  • Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

Prepares/manages department budget: P&L forecasting, operational/capital expenditures, contract negotiations and invoice processing Leads and manages team to accomplish objectives through effective recruitment & selection, training & development, performance management and rewards & recognition.

• Total individual compensation (base salary, short & long-term incentives) offered will take into account a number of factors including but not limited to geographic location, scope & responsibilities of the role, qualifications, talent availability & specialization as well as business needs.

Join our talent community to share your preferences directly with Arch’s Talent Acquisition team.

• Total individual compensation (base salary, short & long-term incentives) offered will take into account a number of factors including but not limited to geographic location, scope & responsibilities of the role, qualifications, talent availability & specialization as well as business needs.

Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus.

If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization..

p>CAPTRUST is seeking a highly skilled and self-driven Senior Specialist Software Engineerto serve as a technical expert in designing and building scalable, cloud-native applications.

As a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner, and safer.

The Document Control Specialist is responsible for managing and optimizing document control processes within the MasterControl Quality Management System (QMS).

We"re looking for engineers who bring fresh ideas from all areas, including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and mobile; the list goes on and is growing every day. As a software engineer, you will work on a specific project critical to Google Cloud"s needs with opportunities to switch teams and projects as you and our fast-paced business grow and evolve.

We"re looking for engineers who bring fresh ideas from all areas, including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and mobile; the list goes on and is growing every day. As a software engineer, you will work on a specific project critical to Google's needs with opportunities to switch teams and projects as you and our fast-paced business grow and evolve.

We"re looking for engineers who bring fresh ideas from all areas, including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and mobile; the list goes on and is growing every day.

We"re looking for engineers who bring fresh ideas from all areas, including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and mobile; the list goes on and is growing every day. In this role, you will be a core member of the Google Cloud Interconnect (GCI) capacity planning and network optimization team, working closely with team leads and cross-functional partners.

We"re looking for engineers who bring fresh ideas from all areas, including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and mobile; the list goes on and is growing every day.

You will partner closely with native designers and web developers, work on the underlying rendering to make graphic designs and effects come to life in Chrome, Android, Wear, Flutter, and many other products across Google.

In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Expertise in SAS programming including SAS/Base, SAS/Lifetest, SAS/Macro, SAS/Graph, SAS/SQL, SAS/ODS, SAS/STAT, SAS/Connect and SAS Access.

Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyones efforts to succeed. Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.

Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications:

• Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.

p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary:

The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.

p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary:

The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.

p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary:

The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.

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Experience in identifying desired capabilities, defining those capabilities, communicating them to a diverse group of developers, engineers, subject matter experts, and users, and generating architectural artifacts to document and manage the achievement of the desired capabilities.

This position can be filled at either a Level 3 or Level 4.

Basic Qualifications for Level 3:

• Bachelor's degree with 5 years of relevant professional experience - OR - Master's degree with 3 years of relevant professional experience - OR - PhD with 1 year of relevant professional experience.

Teams work all across the company, in areas such as information retrieval, artificial intelligence, natural language processing, distributed computing, large-scale system design, networking, security, data compression, user interface design; the list goes on and is growing every day.

With technical and leadership expertise, you manage engineers across multiple teams and locations, a large product budget and oversee the deployment of large-scale projects across multiple sites internationally.

As the only enterprise-grade storage service natively embedded in Google Cloud, AWS, and Microsoft Azure, we empower customers to run everything from traditional workloads to enterprise AI with unmatched performance, resilience, and security. This may cover Health Insurance, Life Insurance, Retirement or Pension Plans, Paid Time Off, various Leave options, Performance-Based Incentives, employee stock purchase plan, and/or restricted stocks (RSU's), with all offerings subject to regional variations and governed by local laws, regulations, and company policies.

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All job offers are contingent upon successful completion of a negative pre-employment drug screen and certain background checks which, unless prohibited by applicable law, may include criminal history checks, employment verification, education verification, DMV checks, and fingerprinting.