QA Complaint Specialist III

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.

Grifols Diagnostic Solutions is seeking a QA Complaints Specialist III. The QA Complaints Specialist III runs assays to support investigations, performs investigation into NAT assay related complaints, participates in CAPAs and performs work related to their area of expertise (including but not limited to assisting in MDR reporting and Audit). This role also maintains laboratory equipment and works collaboratively with interdepartmental teams to ensure investigations are completed and closed out in a timely manner.

We are seeking individuals with a bachelor’s degree and a minimum of 8 years of relatable experience. Candidates must have work experience in handling and investigation in a regulated setting. Experience in technical writing and trend analysis is preferred.          

Responsibilities

• Independently conduct complex complaint investigations through interfacing with field reps. to acknowledge, document, analyze information and data, perform deeper investigation into root causes, and assign additional actions as necessary to close the complaint.
• Leads CAPA investigations and actions, including planning, drafting/approving protocol and design experiments, execution, & effectiveness checks/tracking where applicable. Follows up based on effectiveness check results.
• Performs data trending and prepares periodic reports related to complaints and quality issues and supports post-market surveillance activities
• Coordinates Product Quality Committee meeting to determine appropriate plans for actions to be taken
•  Will serve as a subject matter expert and assist with mentoring and training new hires
• Responsible for running assays to confirm/investigate customer complaints, supporting QA validation studies, and writing test reports
• Provides track and trending for potential health and safety complaints
• Provide Feedback to Mfg/R&D to Improve Quality: Leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements
• Training: Completes training in a timely manner. Maintains training records. Organizes internal cross training/external training sessions.
• Presents results and communicate results within/outside of the group
• Coordinates regional meetings with field service engineers and field service reps
• Maintains laboratory equipment in a calibrated state and completes necessary documentation
• Responsible for taking regular inventory and ordering lab supplies 
• Assist in Audit preparation as needed and prepare reports per auditory/regulatory needs. May be trained as an internal auditor. Address any issues related to the investigation process with the auditor as needed.                                                                                                                                                                                                                           

Knowledge, Skills, and Abilities

• Excellent writing skills, including independently writing investigation reports and reports per auditory/regulatory needs (incl. Post market surveillance report), and review of the reports.
• Experienced presentation skills, including independently preparing and presenting investigation findings.
• Advanced SAP/salesforce experience including data collection and analysis.
• Advanced skills in Excel (data trending analysis), Word, Power Point, Statistical software. Proficiency in data analysis tools including pivot table and other software
• Knowledge of GMPs
• Team oriented and willing to learn new skills
• Good organizational skills and attention to detail
• Demonstrates technical knowledge and sound decision making
• Working knowledge/understanding of analytical assays
• Proactively identifies trends, reports to senior level specialists/management and performs problem solving
• Handles multiple projects and prioritizes accordingly to meet competing deadlines
• Advanced understanding in device regulations, instrument operation and design controls for new product lines
• Ability to train and mentor within and outside the group
• Excellent communication skills and ability to work with a cross-functional team

Education

Requires a bachelor’s degree                                            

Experience

Minimum of 8 years of relatable experience. Work experience in complaint handling and investigation in a regulated setting is required. Experience in technical writing and trend analysis is preferred.                        

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands

Occupational Demands Form # 9:  Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Frequently walks. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  Interacts with others, relates sensitive information to diverse groups.  

Pay Scale

The estimated pay scale for the QA Complaint Specialist III role based in San Diego, CA, is $119,397.60 to $149,247.00 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, 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!

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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

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