Abbott Compliance Analyst in Irving, Texas
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE
We are seeking a Quality Systems & Compliance Specialist to join our Quality Assurance and Compliance Department. The qualified individual should have experience with US and international medical device regulations, guidance documents, industry best practice in all areas of a GMP environment.
Additional Main Responsibilities
Coordinates routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards. [i.e. QMS, QSIT, Regulatory requirements; Notified bodies.].
Recommends and implements Quality process improvements with the approval of Quality Manager
Independently writes and implements controlled documents (i.e., SOPs, Policies, Protocols) which may entail significant system changes.
Maintains knowledge of applicable regulatory requirements and their interpretation. Provides regulatory compliance expertise to the site management by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the site.
Provides training, guidance and coaching to the compliance team auditors (if applicable), team SMEs in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks
Ensure adequate gap analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate.
Develop and analyze meaningful daily, weekly, and monthly reports for senior management.
Schedule and implement plans for comprehensive annual reviews of the regulatory compliance and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
Supports and contributes to strategies for assessing site GMP / GLP processes and implementation to ensure compliance with industry standards.
Communicates confidently and effectively with management, peers, and key stakeholders.
Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
Receives general direction and exercises considerable discretion to own work detail.
Recommends possible solutions
Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight.
Decisions may have short and long-term impact.
IDEAL/PREFERRED EXPERIENCE: 3 (+) years Risk Management/Compliance experience (e.g. ISO 13485, FDA inspections, GMP, Quality Systems), from medical device company (e.g. blood screening or transfusion instrumentation, etc.), or pharmaceuticals company.
QUALIFICATIONS/ REQUIRED EDUCATION, EXPERIENCE, ETC.
Apprenticeship or Bachelor’s Degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience. At least 3 years work experience within an FDA regulated environment with experience in quality compliance; Less experience may be appropriate with advanced degree.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org