Sr. Quality Assurance Officer

4 weeks ago

Cary, United States Allucent Full time
Job DescriptionJob Description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Quality Assurance Officer (Sr. QA Officer) to join our A-team (hybrid*/remote). As a Sr. QA Officer at Allucent, you are responsible for the coordination, development and management of Quality Management Systems documents (e.g., SOPs, training, sponsor documents). This position performs audits (e.g., process, project, vendor, investigator site), as appropriate, hosts customer audits, participates in regulatory inspections, performs quality control review of regulatory documents as needed, and supports quality issue/deviation investigations as directed of Allucent Quality Department.

In this role your key tasks will include:

  • Development and management of quality documentation, to included but not limited to, SOPs, training, sponsor documentation
  • Hosts customer audits
  • Participates in regulatory inspections
  • Perform audits (e.g., process, project, vendor, investigator site), as appropriate
  • Performs quality control review of regulatory documents as needed
  • Supports quality issue/deviation
  • Actively support staff learning & development within the company
  • Draft and contribute, as Subject Matter Expert (SME) in the field of Sr. Quality Officer, activities in the evaluation/improvement of processes and procedures within the Quality Management System.
  • Assure good communication and relationships with (future) clients
  • Contribute and take part in client evaluations, visits and bid defense
  • Support other quality activities (e.g., vendor audits, internal process audits, investigator site audits) as directed
  • Contribute to other areas of business and other duties as assigned

Requirements

To be successful you will possess:

  • Life science, healthcare and/or business degree
  • Minimum 4 years of relevant work experience
  • Minimum 2 years of experience in drug development and/or clinical research
  • Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
  • Reside in the USA (East Coast Region)
  • Process oriented
  • Analytical skills
  • Strong written and verbal communication skills including good command of English language
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced challenging environment of a growing company
  • Administrative excellence
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required
  • Excellent organizational skills
  • Auditing & SOP experience.
  • Experience hosting audits
  • Experienced translating complicated regulations/rules into clear and usable recommendations
  • Business travel is required for this position as needed; 25% or less
  • Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
  • Analytical & Process oriented with developing leadership skills
  • Strong written and verbal communication skills including good command of English language
  • Effective at problem solving, strategic thinking and conflict resolution

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-DF1

  • Quality Assurance Manager

    3 weeks ago

    Cary, United States Azzur Group Full time

    DescriptionAzzur Group is looking for a Quality Assurance Manager to oversee, manage, and execute the company's quality assurance programs. The Quality Manager will be responsible and responsible for ensuring the QMS is implemented and followed. Responsibilities:A) Performing Test Conducting and reviewing investigations and clients exceeded concerns...

  • Quality Assurance Manager

    2 weeks ago

    Cary, United States Azzur Group Full time

    Description Azzur Group is looking for a Quality Assurance Manager to oversee, manage, and execute the company's quality assurance programs. The Quality Manager will be responsible and responsible for ensuring the QMS is implemented and followed. Responsibilities:A) Performing Test Conducting and reviewing investigations and clients exceeded concerns...

  • Quality Assurance Associate II

    1 month ago

    Cary, United States Eurofins USA BioPharma Services Full time

    Job Description Supports all Quality Assurance I roles as required Supports administrative function by: monitoring quality systems deadlines and reports to management pending and overdue activities assisting in Analytical Subcontractor documentation maintenance assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change...

  • Quality Assurance Associate II

    2 weeks ago

    Cary, United States Eurofins USA BioPharma Services Full time

    Job DescriptionJob DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on,...

  • Quality Assurance Associate II

    1 week ago

    Cary, United States Eurofins Full time

    Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with...

  • Quality Assurance Manager

    1 month ago

    Cary, United States Scientific Calibration Inc. Full time

    Job DescriptionJob DescriptionDuties and ResponsibilitiesDevelop, implement, and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulationsMaintain compliance with ISO 17025, GMP, GLP and other necessary accreditations.Create, revise, review and approve documentation, records, and SOPs.Develop mechanisms to...

  • Quality Assurance Manager

    3 weeks ago

    Cary, United States PCB Piezotronics, Inc. Full time

    The Primary objective for our Quality Assurance Manager role is to establish and maintain a robust quality system by creating improvements and overseeing the maintenance of our Temposonics Quality system. This would include implementing standards and procedures to control product quality and reliability. The Quality Assurance Manager will be responsible for...

  • Quality Assurance Manager

    3 weeks ago

    Cary, United States PCB Piezotronics, Inc. Full time

    The Primary objective for our Quality Assurance Manager role is to establish and maintain a robust quality system by creating improvements and overseeing the maintenance of our Temposonics Quality system. This would include implementing standards and procedures to control product quality and reliability. The Quality Assurance Manager will be responsible for...

  • Quality Assurance Manager

    1 week ago

    Cary, United States PCB Piezotronics, Inc. Full time

    The Primary objective for our Quality Assurance Manager role is to establish and maintain a robust quality system by creating improvements and overseeing the maintenance of our Temposonics Quality system. This would include implementing standards and procedures to control product quality and reliability. The Quality Assurance Manager will be responsible for...

  • Sr. IA Engineer with Security Clearance

    2 months ago

    Cary, United States Zachary Piper Solutions, LLC Full time

    Zachary Piper Solutions is currently seeking an Sr. Information Assurance Engineer supporting the Army Reserve National Guard in Cary, NC. Responsibilities for the Sr. Information Assurance Engineer include: * The role will work within a team that supports a wide variety of security activities including supporting third party assessment and authorization...

  • Engineering Technician

    3 weeks ago

    Cary, United States NV5 Global , Inc. Full time

    NV5 is seeking an Engineering Technician for our Cary, NC location. This role is also open to those in Fayetteville, NC; Rocky Mount, NC; and Burlington, NC. Responsibilities include monitoring activities on construction sites and performing testing Quality Assurance, Technician, Technical, Construction, Engineer, Quality, Technology

  • Sr. Accountant

    2 weeks ago

    Cary, United States Creative Financial Staffing Full time

    Creative Financial Staffing has partnered with an internationally recognized, award winning professional services company that has expanded and is looking for a Sr. Accountant. This is a dynamic, fast paced environment where new ideas and process improvements are encouraged, enabling you to make an impact company wide. Highlights of the Sr. Accountant...

  • Sr. Accountant

    1 week ago

    Cary, United States Creative Financial Staffing Full time

    Creative Financial Staffing has partnered with an internationally recognized, award winning professional services company that has expanded and is looking for a Sr. Accountant. This is a dynamic, fast paced environment where new ideas and process improvements are encouraged, enabling you to make an impact company wide. Highlights of the Sr. Accountant...

  • Sr. Accountant

    20 hours ago

    Cary, United States Creative Financial Staffing Full time

    Creative Financial Staffing has partnered with an internationally recognized, award winning professional services company that has expanded and is looking for a Sr. Accountant. This is a dynamic, fast paced environment where new ideas and process improvements are encouraged, enabling you to make an impact company wide. Highlights of the Sr. Accountant...

  • Engineering Technician

    3 weeks ago

    Cary, United States NV5 Full time

    Overview: NV5 (NASDAQ: NVEE) provides engineering and consulting services to public and private sectors, delivering solutions through five business verticals: Construction Quality Assurance, Infrastructure, Utility Services, Program Management, and Environmental. With offices nationwide and abroad, NV5 helps clients plan, design, build, test, certify, and...

  • Associate Project Manager

    1 week ago

    Cary, United States NV5 Global, Inc Full time

    Overview NV5 (NASDAQ: NVEE) provides engineering and consulting services to public and private sectors, delivering solutions through five business verticals: Construction Quality Assurance, Infrastructure, Utility Services, Program Management, and Environmental. With offices nationwide and abroad, NV5 helps clients plan, design, build, test, certify,...

  • Associate Project Manager

    2 months ago

    Cary, United States NV5 Global, Inc Full time

    Overview NV5 (NASDAQ: NVEE) provides engineering and consulting services to public and private sectors, delivering solutions through five business verticals: Construction Quality Assurance, Infrastructure, Utility Services, Program Management, and Environmental. With offices nationwide and abroad, NV5 helps clients plan, design, build, test, certify,...

  • Sr. SAP Technical Project Manager

    3 weeks ago

    Cary, United States Genius Business Solutions Full time

    Job DescriptionJob Description Sr. SAP Technical Project Manager | Cary, NC / Malvern, PA | 12+ months. Work you'll do/Responsibilities: Must have 10+ years of experience in at least 1 module in order of priority CS, SD, MM or PP Must have strong communication skills Must have last few years working as a lead or project manager 15+ years of consulting...

  • Sr. SAP Technical Project Manager

    1 month ago

    Cary, United States Genius Business Solutions Inc. Full time

    Job DescriptionJob DescriptionSr. SAP Technical Project Manager | Cary, NC / Malvern, PA | 12+ months. Work you'll do/Responsibilities:Must have 10+ years of experience in at least 1 module in order of priority CS, SD, MM or PPMust have strong communication skillsMust have last few years working as a lead or project manager15+ years of consulting...

  • Quality Assurance PASRR Evaluator

    2 weeks ago

    Cary, United States Acentra Health Full time

    Job DescriptionJob DescriptionCNSI and Kepro are now Acentra Health! Acentra Health exists to empower better health outcomes through technology, services, and clinical expertise. Our mission is to innovate health solutions that deliver maximum value and impact.Lead the Way is our rallying cry at Acentra Health. Think of it as an open invitation to embrace...