Talent.com
Staff Specialist, Compliance

Staff Specialist, Compliance

Thermo FisherCarlsbad, CA, US
3 days ago
Job type
  • Full-time
Job description

Staff Specialist, Compliance

Company : Thermo Fisher Scientific, Inc.

Location : 5781 Van Allen Way, Carlsbad, CA 92008

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 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 : Bachelor's 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 Master's 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 : $142,174 to $158,500 per year

Compensation and Benefits : The salary pay range estimated for this position Staff QA Engineer based in California is $142,147.00$158,500.00. 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 : https : / / jobs.thermofisher.com / global / en / total-rewards

Create a job alert for this search

Compliance Specialist • Carlsbad, CA, US

Related jobs
  • Promoted
Certified Payroll Specialist

Certified Payroll Specialist

Garney ConstructionTemecula, CA, United States
Full-time
DIR reporting, auditing, and maintaining LCP (Labor Compliance Program) Tracker.We are seeking an experienced and detail-oriented CA Payroll Compliance Coordinator to join the Garney team.This role...Show moreLast updated: 30+ days ago
  • Promoted
Tax Expert - Onsite

Tax Expert - Onsite

IntuitTemecula, CA, United States
Full-time
Intuit is seeking highly motivated individuals to join our dynamic team as dedicated TurboTax Live Seasonal Local Service Experts in one of our new TurboTax locations across the United States on a ...Show moreLast updated: 18 days ago
  • Promoted
  • New!
Lead Validation Specialist

Lead Validation Specialist

VirtualVocationsEscondido, California, United States
Full-time
A company is looking for a Lead Validation Specialist with experience in clinical systems.Key Responsibilities Provide project leadership to the validation team, ensuring compliance with GxP regu...Show moreLast updated: 11 hours ago
  • Promoted
  • New!
Security Lead

Security Lead

VirtualVocationsEscondido, California, United States
Full-time
A company is looking for a Security Lead to build and manage its security function across governance, engineering, and operations. Key Responsibilities Own the company's security posture from code...Show moreLast updated: 15 hours ago
  • Promoted
Partner- Bankruptcy and Restructuring

Partner- Bankruptcy and Restructuring

EisnerAmperLa Jolla, CA, United States
Full-time
At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact.Whether you're starting out in your career or taking your next step as a seasone...Show moreLast updated: 30+ days ago
  • Promoted
Seasonal Recovery Champion Associate, Temecula Promenade - Full Time

Seasonal Recovery Champion Associate, Temecula Promenade - Full Time

Macy'sTemecula, CA, US
Full-time
Macy’s is more than just a store.One that’s captured the hearts and minds of America for more than 160 years.A story about innovations and traditions…about inspiring stores and i...Show moreLast updated: 4 days ago
  • Promoted
Grants Compliance Senior Specialist, Community Partnerships & Investments

Grants Compliance Senior Specialist, Community Partnerships & Investments

Wounded Warrior ProjectSan Diego, CA, United States
Full-time
We know these are some of the things people look for in a job.If you're the kind of person who believes that honoring and empowering our nation's veterans is more than just a cause - that it's a ca...Show moreLast updated: 30+ days ago
  • Promoted
CPA Accounting Specialist

CPA Accounting Specialist

VirtualVocationsEscondido, California, United States
Full-time
A company is looking for a Senior Specialist Accountant in External Reporting.Key Responsibilities Prepare and review consolidated financial statements and disclosures for SEC filings Research a...Show moreLast updated: 30+ days ago
  • Promoted
Client Accounting Manager - Outsourced Accounting & Bookkeeping

Client Accounting Manager - Outsourced Accounting & Bookkeeping

EisnerAmperLa Jolla, CA, United States
Full-time
At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact.Whether you are starting out in your career or taking your next step as a season...Show moreLast updated: 3 days ago
  • Promoted
Cyber Accounting Adjunct Faculty

Cyber Accounting Adjunct Faculty

VirtualVocationsOceanside, California, United States
Full-time
A company is looking for an Adjunct Faculty member in Accounting and CyberAccounting.Key Responsibilities Teach courses in Accounting Information Systems, CyberAccounting, Cyber Forensics, Inform...Show moreLast updated: 3 days ago
  • Promoted
Medicaid Enrollment Specialist

Medicaid Enrollment Specialist

VirtualVocationsOceanside, California, United States
Full-time
A company is looking for a Medicaid Enrollment Specialist.Key Responsibilities Serve as the primary subject matter expert for Medicaid enrollment, revalidations, and contract maintenance Prepare...Show moreLast updated: 2 days ago
  • Promoted
Behavior Specialist

Behavior Specialist

VirtualVocationsOceanside, California, United States
Full-time
A company is looking for a Behavior Specialist to join their team.Key Responsibilities Develop, facilitate, document, and revise Behavior Support Plans in accordance with individual support plans...Show moreLast updated: 1 day ago
  • Promoted
Senior Compliance Specialist (San Diego Onsite)

Senior Compliance Specialist (San Diego Onsite)

Neurocrine BiosciencesSan Diego, CA, US
Full-time
Compliance Specialist will be a valued member of the Ethics & Compliance Team responsible for implementing the Company's Ethics & Compliance Program. The position will have a wide-range of responsib...Show moreLast updated: 30+ days ago
Regulatory & Compliance Specialist

Regulatory & Compliance Specialist

CorDxSan Diego, CA, US
Full-time
Quick Apply
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.With over 2,100 employees across the world, serving millions of users in over 100...Show moreLast updated: 30+ days ago
  • Promoted
37F PsyOp Specialist

37F PsyOp Specialist

U.S. ArmySan Diego, CA, US
Full-time +2
As a Psychological Operations Specialist, you’ll be an expert at persuasion.You’ll assess and develop the information needed to influence and engage specific audiences. You’ll broadcast important in...Show moreLast updated: 2 days ago
  • Promoted
  • New!
Payroll Lead

Payroll Lead

VirtualVocationsEscondido, California, United States
Full-time
A company is looking for a Payroll Lead to join their Finance team and manage payroll compliance for employees across the U. Key Responsibilities : Develop and streamline internal payroll and emplo...Show moreLast updated: 7 hours ago
  • Promoted
  • New!
Healthcare Compliance Auditor

Healthcare Compliance Auditor

VirtualVocationsOceanside, California, United States
Full-time
A company is looking for a Healthcare Compliance Auditor - Enterprise Risk.Key Responsibilities Assist in reviewing coding, billing, and claims processing policies to develop compliance monitors ...Show moreLast updated: 9 hours ago
  • Promoted
QA Operations Specialist

QA Operations Specialist

Novartis Group CompaniesCarlsbad, CA, United States
Full-time
Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Ma...Show moreLast updated: 30+ days ago