Regulatory Compliance Associate

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.

Job Summary:

This position will be responsible for supporting internal cGxP, domestic and international supplier audits as well as compose audit responses and corrective actions to ensure company compliance with internal processes.

This position will include the following major areas of responsibility:

• Support internal cGxP audits.
• Support domestic and international supplier audits.
• Participate in customer, third party, and national or international regulatory agency audits. Prepare quality agreements.
• Prepare reports

Responsibilities will include writing summary reports (including trends, tables, graphs, and slides), participating in the audit response and corrective action process, and verifying the implementation and effectiveness of corrective actions. Additional roles include writing and revising documents and procedures, conducting training on procedures, cGxP, industry standards, hold and attend meetings, give presentations. This position will interface with others in and out of the company up to the vice president level.

Essential Job Duties:

• Support and/or perform internal and GLP compliance audits of GB's manufacturing, testing and warehouse facilities and operations. Support and/or perform cGMP and GLP compliance audits of GB's suppliers and contract laboratories. This may require approximately 10% domestic and international travel. (This will not be the primary focus of this position)
• Coordinate, schedule and participate in audit activities associated with GB's customers. Participate and assist in the activities associated with regulatory inspections of GB. Coordinate and participate in corporate audits.
• Support and facilitate the development, coordination and presentation of training programs within the areas of responsibility for the department and for others. Maintain current knowledge of regulatory and industry standards, trends and advancements.

Internal Audits:

• Perform walkthrough of all GxP areas (e.g. manufacturing, quality control, warehouse, facilities, and operations) to evaluate areas are in a state of compliance with applicable regulations.
• Follow up audit reports and related documents, assist with audit responses, verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions. This includes the issuance, tracking, review, and follow up of CAPAs relating to audits.
• Evaluate all GxP areas for its effectiveness in achieving the quality objectives established, as well as compliance with the applicable regulations. Support the preparation, performance, and responses, and CAPA management to corporate quality audits.

Supplier Audits:

• Support supplier audits. May require approximately 10 % domestic and international travel.
• Follow up on reports and related documents verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions.
• Maintain professional and good working relationships with suppliers.

External (Regulatory/Customer):

• Participate and assist in the activities associated with external inspections. Coordinate audit preparation and post audit activities.
• Track and follow up on corrective and preventive actions, near misses derived from external inspections, including CAPA tracking. Negotiate terms with suppliers.
• Coordinate with and obtain legal input. Track and follow up status.

Quality Agreements:

• Draft and revise quality agreements.
• Evaluate quality agreement for its effectiveness in achieving quality objectives established, as well as compliance with the applicable regulations.

Others:

• Maintain the CAPA program for CAPAs related to audits. Follow up with responsible management to ensure timely and complete corrective actions. Hold CAPA meetings and present issues to management.
• Process change notification originating from sister companies. Issue notifications to applicable customers for internal changes.
• Issue and review supplier corrective action reports related to raw material issues. Follow up with suppliers. Evaluate the acceptability of supplier investigations and corrective actions.
• Follow established regulation, procedure, training, and due date.

Requirements:

• Bachelor’s degree in one of the Life Sciences, Health Care or other Science or Engineering fields, or the equivalent of two years of industry experience is preferred.
• Industry experience within the Pharmaceutical, Biologics, Medical Device or Health Care Industry, which applies Quality Assurance or Quality Engineering practices. At least 5 years of experience in Regulatory Affairs, Compliance, Quality Engineering, Quality Control or Quality Assurance with emphasis on conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers.
• Working knowledge and understanding of concepts of GxP (e.g.cGMP and GLP). These practices should include other appropriate governmental and/or industry such as (ASQ, RAPS, CPA, ISO etc.).
• Understanding of industry standard operational/manufacturing practices.  Knowledge of US regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products. Familiar with ISO requirements. 
• Good, verbal, written and negotiations skills. 
• Computer literacy with proficiency in MS word, Access, and knowledge of Excel and PowerPoint. 
• Able to work independently with minimal supervision. 
• Well-developed communication skills especially in stand-up presentation or facilitation. 
• Lead person qualities and interpersonal skills, being able to direct the work of others. 
• Willing to adhere to Manufacturing and QC Laboratory gowning procedural requirements.
• Specific experience with SAP preferred.
• Demonstrated leadership skills with the ability to motivate, guide, train, and coach department personnel. Ability to work independently with minimal supervision. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. Must be proactive, results oriented, and have strong attention to detail
• Self-starter with strong work ethic and the ability to exercise good judgement. Ability to effectively prioritize and manage multiple tasks to meet targeted timeframes. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Must be flexible with working hours/shifts to accommodate the 24-hour, 7-day plant operation.

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 for the Regulatory Compliance, Associate role based in Los Angeles, CA, is $73,913 - $85,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 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!

*This job description is accurate at the date of publication.  It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position.  Other duties may be assigned and qualifications required may change over time.

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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