Audit and Compliance - Quality Assurance Specialist

GRIFOLS, S.A.

14d•Hybrid

About The Position

Supports and assesses activities that ensure organizational adherence to corporate quality and compliance processes, including quality management systems reviews, data integrity assessments, and risk management assessments. Coordinates with donor centers and shared services with external inspections (e.g. regulatory, customer, etc.). Aids with audit planning, audit responses, and Plasma Master File (PMF) updates to maintain donor center compliance with regulatory requirements, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), and customer requirements.

Requirements

The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
They must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
They must know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
They must have strong interpersonal skills with the ability to communicate effectively with persons from other cultures and other points of view.
Maintains a high level of professionalism.
Follows policies, procedures, and regulations governing work and the work environment.
Models and demonstrates high standards of integrity, trust, openness, and respect for others.
Takes initiative; looks for opportunities to act and contribute to the team's success.
Demonstrates good stewardship of expenses, makes good use of unsupervised time.
Offers support to team members at any level in achieving their goals.
Provides outstanding servant leadership and receives feedback constructively.
Appropriately follows the chain of command and knows how to get tasks accomplished.
Demonstrates openness to team members’ suggestions.
Shares knowledge, resources, etc. to reach common goals.
Demonstrates effective oral and written skills and communicates information accurately based on fact.
Uses respectful, conversational tones in e-mail messages.
Understands the impact of own behavior on others – and adapts to change with optimism.
Ability to think through problems clearly and logically.
Completes assigned tasks within the required timelines.
Demonstrates Critical thinking and attention to detail.
Listens and communicates in a transparent way, building relationships that foster professional self-esteem.
Acts as a role model of the corporate values and reinforces them among his/her team.
Uses facts and figures to support positions and influence others.
Promotes and applies professional ethics.
Knowledgeable of current regulatory standards.
Organizes tasks and projects effectively.
Demonstrates and encourages good teamwork and high levels of collaboration.
Contributes feedback where necessary.
May represent Compliance on projects, workgroups, Process Improvement Teams.
Builds strong and trustworthy working relationships with team members and internal / external partners.
Focuses on the scope and the solution rather than the problem; strives to overcome possible obstacles.
Shares innovative ideas, creates buy-in and translates ideas into practice.
Looks for simplification and improvement of processes; creates simple procedures and alternatives that may benefit the company.
Embraces change and continuous improvement
Bachelor’s Degree Required
5 years of experience

Responsibilities

Prepares Site Master Files (SMFs) required for external EMA inspections through collaboration with donor centers and center support leadership.
Represents organization by providing on-site or remote support during inspections by Regulatory Authorities.
Responsible for center support leadership and developing, writing, and reviewing external audit responses / CAPA plans related to donor center citations.
Responsible for developing, writing, and reviewing both internal and external audit responses / CAPA plans related to corporate citations.
Coordinates and organizes final responses to regulatory inspections / audits (FDA, EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits).
Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses.
Ensures donor center and corporate operations are compliant with Domestic / European regulations through routine procedure and process review.
Recognizes areas of improvement through review of audit findings and offers solutions to enhance compliance to Domestic / European regulations, Standard Operating Procedures (SOP), and customer requirements.
Evaluates the need for change and initiates Change Requests and writes Standard Operating Procedures based on trends, audit findings, or interaction with facilities.
Assesses Corporate deviations and tracking / trending data to ensure continuous improvement.
Reviews Quality Risk Assessments and coordinates with center support leadership to ensure timely and accurate documentation and closure.
Performs Data Integrity Risk Assessments.
Represents the Department with organizational initiatives to ensure compliance with regulations, Standard Operating Procedures, and customer requirements.
Travels up to 25% or greater if demand requires.