QA CSV and Data Integrity Specialist Quality Assurance

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

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.

What You’ll Do Here

• 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.

What You’ll Need to Succeed

• 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.

What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Reviews

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.  Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!