Sr. Compliance Associate (Compliance Auditor)

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary:

This position entails performing routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, providing compliance guidance and support throughout the Quality organization, training delivery, and leading multi-departmental teams and initiatives.

To ensure success as a Compliance Auditor, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and/or GMP auditing and demonstrated project management experience in leading cross-functional teams.

Key Responsibilities

• To ensure success as a Compliance Auditor, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing and demonstrated project management experience in leading cross-functional teams.
• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assisting in implementing Internal Audit plans for all Grifols manufacturing plants including GB
• Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants including GB.
• Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses.
• Peer Review of Audits Reports.
• Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Keeping abreast of industry standards and regulations.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
• Contribution to the continuous improvement of the Quality Management System is required.
• Other additional duties may be assigned by the Senior Manager, Quality Audits from time to time if required.
• Ability to travel (up to 50%)

Key Competencies

Skills:

• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Effective influence management and conflict resolution abilities.
• Highly developed investigative and reporting skills.
• Effective organisation and time management skills.
• Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups

Abilities:

• Ability to travel.
• Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
• Flexible, able to adapt quickly to change in a fast-paced environment.

Knowledge:

• Minimum Bachelor's degree in a scientific discipline.
• Minimum of 5+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing.
• ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
• Superior knowledge of U.S. cGMPs and FDA guidance.
• Superior knowledge of EU GMPs, Annexes and ICH Guidance's and International Standards
• Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.
• Experience in working in a sterile manufacturing facility.

LEVELS:

• Sr. Compliance Associate I is $90,000 - $100,000

• 5+ years experience

• Sr. Compliance Assoicate level II is $110,000 - $115,000

• 6 + years expereince

Occupational Demands : Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.

The estimated pay scale in Los Angeles, California for Sr. Compliance Associate I is $90,000 - $100,000 per year AND/OR Sr. Compliance Assoicate level II is $110,000 - $115,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA

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