Senior quality assurance auditor job description

Do you have GLP/GCP auditing experience? If so, we want you to join our Global QA team as a Senior QA Compliance Auditor in Somerset, NJ.

Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

We are offering a sign-on bonus of $5,000 (paid after 60 days of employment; external candidates only)

Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
Report on relevant quality metrics (for multiple topics/departments) and highlight trends Provide consultation to the operational team (e.g. as they revise/write controlled documents) Delivery of training in performance of audits (basic, intermediate audit activities) Work with operational management to support Quality topics and/or working on projects with QA team on other sites (showing development of collaboration skills) Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization Create and/or re-write QA SOPs based on findings from local quality initiatives. Organizing, Prioritizing and Managing all aspects of workload to meet business needs. Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
Education/Qualifications


A minimum of a Bachelor's Degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable Experience may be substituted for education
Experience


6 years' in regulatory environment (experience in GLP/GCP roles preferred) Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance Experienced GLP/GCP auditor Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios


Labcorp is proud to be an Equal Opportunity Employer:


As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Quality Assurance Auditor or Sr. Auditor (Hybrid - Troy MI)

Location
Headquarters-Troy, MI

Job Summary
This individual will provide support and development efforts as we create leading Internal Audit practices and assist in QAIP (Quality Assurance and Improvement Program) oversight to ensure compliance with Institute of Internal Audit (IIA) Standards and regulatory guidelines as it relates to the monitoring, performance and execution of the audit process, standards, and methodology. The individual may perform special projects as well as assist in implementing changes to existing processes for improved audit efficiency and effectiveness.

Job Responsibilities:
(30%) Develop, plan and execute quality assurance and process improvement work plans which are consistent with IIA, Internal Audit Methodology, and other regulatory guidelines.
(25%) Perform various reporting tasks such as Audit Committee materials, management reporting, internal KPIs, regulatory exam requests, and ad hoc reporting as needed.(25%) Assist in developing and coordinating the risk assessment and annual audit planning process.(20%) Perform other duties as needed, such as documenting training materials and working with the audit teams on best practice recommendations.

Job Requirements:

Auditor:
Minimum of 3 years of experience working in Internal Audit, bank operations, financial, risk, or similar type of function required for QA Auditor role.Bachelor's Degree Required (Accounting, Finance, Technology, or related field) Financial services or other highly regulated industry experience is preferred.Excellent interpersonal communication skills (written & verbal).Strong analytical and technical skills (e.g., Excel, PowerPoint, other data analysis tools).Ability to work independently with minimal direction and guidance and providing leadership in the area of internal audit knowledge and best practices.Strong organizational and critical thinking skills.Ability to work well with various levels of management.CIA, CPA, CISA, CRCM, or CFE Certifications are preferred.Up to 10% travel required.

Sr. Auditor:
Minimum of 5 years of experience working in Internal Audit, bank operations, financial, risk. Experience in a professional practices and quality assurance function is desired.Bachelor's Degree Required (Accounting, Finance, Technology, or related field) Financial services or other highly regulated industry experience is preferred.Excellent interpersonal communication skills (written & verbal) with the ability to provide effective challenge.Strong analytical and technical skills (e.g., Excel, PowerPoint, other data analysis tools).Ability to work independently with minimal direction and guidance and providing leadership in the area of internal audit knowledge and best practices.Strong organizational and critical thinking skills.Ability to work well with various levels of management.Ability to lead special projects with limited supervision.CIA, CPA, CISA, CRCM, or CFE Certifications are preferred.Up to 10% travel required.

Internal Use Only: Job Band G/F

The SR Quality Assurance Auditor is responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of FK facilities and external audits of FK suppliers in accordance with FK policies and procedures. Identifies top compliance risks and communicates to FK Management.
Benefits begin first day: Medical, Dental, Vision, and FSA. Hybrid role, when not traveling.

Responsibilities

Internal Audits
Lead internal audits of FK facilities based on the FDA System Based Inspection Policy and general cGMP. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.Lead/participate in Global internal audits of Fresenius Kabi facilities as required. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings to FK and FK USA management.Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.Lead gap assessment audits and PAI readiness inspections at FK USA facilities as needed.Prepare monthly reports of completed activities including trend analysis, if required and submit to the Sr. Manager, QA Compliance and Senior QA Management.

External Audits
Lead external audits of FK raw material suppliers including Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, and Contract Laboratories. Develop audit plan, conduct quality audit, prepare audit reports and communicate findings, including compliance risk. Recommends approval or disapproval of suppliers based on compliance assessment.Review and evaluate supplier's audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet FK specifications and quality requirements. Follow-up on prior audit recommendations to ensure implementation and compliance.Assist in the maintenance of the annual internal and external audit schedules as requested by management.Lead for cause audits of external suppliers as request by management.

Other Activities
Assist in and/or lead the development of compliance and quality training as required.Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.Maintain audit files and databases to ensure all documentation is current and complete.Assumes additional duties and responsibilities as assigned.

Requirements
Bachelors degree in the Sciences (Masters preferred) with a minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical or biotech industries preferred but combination with medical device experience is acceptable. Certification as a CQA Auditor, CQE etc preferred.Minimum 4 years of experience in pharmaceutical quality audits including both external and internal auditing. At least one year of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, cGMP and GLP regulations is required.Display in-depth understanding of FDA trends, FDA and EU regulations and guidelines and ISO 9001:2008. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.Demonstrated ability to lead teams and handle project management activities with supervision.Must be able to travel domestically and/or internationally up to 75% of the time.Demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.Effective communication skills and technical writing ability.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.