Job Information
Allucent Sr. Quality Assurance Officer (United States) in United States
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
For US candidates, East Coast (eastern time zone) is preferred
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 (https://www.allucent.com/careers) .
“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.”
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