Staff Specialist, Compliance

Work Schedule

Environmental Conditions

Job Description

COMPANY: Thermo Fisher Scientific Inc.

LOCATION: 5781 Van Allen Way Carlsbad CA 92008

TITLE: Staff Specialist Compliance

HOURS: Monday to Friday 8:00 am to 5:00 pm

DUTIES: Ensure compliance with applicable local state federal and international regulations and standards (e.g. FDA ISO GMP).

Stay current with changes in regulatory requirements and industry standards and disseminate relevant information to the organization.

Create and oversee self-inspection program perform Internal Audits and lead all aspects of functional walk-throughs to ensure compliance to corporate directives site procedures and regulatory expectations.

Conduct risk assessments related to product quality and regulatory compliance and implement risk mitigation strategies and monitor their effectiveness.

Prepare and maintain detailed reports records and documentation related to compliance activities.

Lead Audit Readiness through design and execution of risk management program including communication risk register and risk mitigation strategy to the Quality Head and Site Leadership Team to ensure the site is inspection ready at all times.

Host Regulatory Inspections Corporate audits and client audits. Collaborate with clients auditors and regulator agents and represent the site during inspectors and meetings to ensure information is provided in a timely accurate and complete manner.

Responsible for timely and effective execution of both internal and external audit commitments. Interact with SMEs in all functional areas to lead the development and implementation of Corrective and Preventative Actions (CAPAs) in response to any audit/inspection findings.

Collect analyze trend and report-out-monthly on quality for measurement of compliance risk to able to drive initiatives to mitigate those risks.

Partner with Regulatory to assess new or revised regulations and standards to ensure organization fulfill changing regulatory and industry needs.

Assess updates to Corporate Policies SOPs and Guidance Documents for impact to site procedures and ensures timely closure of gaps.

Ensure that the site quality systems are accurately supported to ensure compliance with applicable standards.

Support in change controls activities for document and manufacturing processes.

Identify opportunities for process improvements and lead initiatives to enhance quality and compliance.

Develop and deliver training program on quality and compliance topics for staff at all levels.

TRAVEL: Up to 10% domestic and international travel required.

REQUIREMENTS: Bachelors degree or foreign degree equivalent in Industrial Engineering Biomedical Engineering Biotechnology or related field of study plus 7 years of experience as a Quality Engineer Quality Specialist Complaints Analyst or any occupation in which the required experience can be obtained or related experience. Employer will also accept a Masters degree or foreign degree equivalent in Industrial Engineering Biomedical Engineering Biotechnology or related field of study plus 5 years of experience as a Quality Engineer Quality Specialist Complaints Analyst or any occupation in which the required experience can be obtained or related experience.

Required knowledge or experience with:

21CFR 820 ISO9001:2015;

Analyzing complex regulations and their impact on business operations;

Quality Management System design and oversight;

Reviewing documents and processes to ensure compliance;

Conveying compliance information to various stakeholders in global leadership;

Identifying compliance issues and developing effective solutions;

Overseeing the resolution of compliance issues and implementation of corrective actions;

Identifying process gaps and driving continuous improvement initiatives to enhance performance;

Hosting customers and notified body audits and regulatory inspections ensuring effective communication with auditors/inspectors;

Auditing skills including ability to plan execute and report on internal and external audits;

Application of quality tools: Risk Analysis Root Cause Analysis;

Compliance specific software programs: OCPLM Trackwise LIMS ERP;

Statistical methods and tools to analyze quality systems data identify trends and support decision-making processes; and

Ethically handling confidential information.

Salary: $142174 to $158500 per year

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Staff IC