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QA CSV and Data Integrity Specialist
@220 Altasciences Company Inc
[Hiring] QA CSV and Data Integrity Specialist @220 Altasciences Company Inc
Mar 25, 2025 - 220 Altasciences Company Inc is hiring a remote QA CSV and Data Integrity Specialist. 💸 Salary: unspecified. 📍Location: Canada.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
Responsible for providing Quality assurance oversight, collaboration and review of Computerized System (CSV) Lifecycle validation deliverables and supporting corporate Data Integrity initiatives for GCP, GLP and GMP programs as specified in company protocols and SOPs.
- Provide Quality oversight, review and audit of CSV and equipment validation documentation.
- Support client audits, computer system vendor qualifications and audits, and regulatory inspections as needed.
- Provide QA support and input to enforce CSV and Data Governance guidelines, policies and procedures.
- Assist with revision or creation of SOPs, policies as well as QA tools and templates, with related training, related to CSV and Data Integrity.
- Help develop QA auditing guides and tools for validated systems.
- Support the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11 and applicable FDA/EMA Guidances on electronic data integrity.
- Participate in site, business unit, and corporate quality and process improvement initiatives related to CSV and Data Integrity as needed.
- Communicate all identified compliance and quality risks to management.
- Assist in conducting data integrity risk assessments and consult in risk mitigation strategies as needed.
- Other duties as assigned.
Qualifications
- Bachelor's degree (B.S.) or higher, specializing in a scientific or equivalent combination of education and experience.
- 3+ years related experience as a quality assurance professional specific to computer system validation and regulatory compliance oversight in a regulated environment.
- Professional certification such as RQAP-GLP or GCP (Registered Quality Assurance Professional-GLP or GCP) or ASQ-CQA (American Society of Quality Certified Quality Auditor) or other certification is recommended.
- Basic computer skills (Microsoft Office Suite) required.
- Excellent verbal and written communication skills.
- Well developed interpersonal skills are required.
- Personal/professional integrity and proven discretion in handling confidential information.
- Ability to develop strong trusting relationships in order to gain support and achieve results.
- Capable of managing multiple conflicting priorities.
- Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
- Relevant industry experience a plus.
- Knowledgeable in 21 CFR 11, 210, 211, GAMP5, and applicable regulatory guidance documents specific to Computerized systems and Data Integrity.
- Understanding of data governance and ALCOA++ principles.
- Ability to solve practical problems and deal with a variety of concrete variables.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Demonstrates attention to detail.
Benefits
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews
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| 📍 | Be aware of the location restriction for this remote position: Canada |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
QA
QA
|
Salary
💸
unspecified
|
Remote
Location
Canada
|
|
Job Type
full-time
|
Posted
Mar 25, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: Canada |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
