Sr. QA Specialist

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.

Summary:

This position will be responsible for the review of batch documentation and the preparation of product releases and submissions to regulatory agencies. This is a senior level position.

Primary Responsibilities:

• Responsible for the preparation of certificate of analysis, certificate of compliance and export protocols.  May also be required to act as a verifier/ certifier of the above documents.
• Prepares product submission protocols for FDA review and approval.
• Maintains change control files for Release Office documents.
• Responsible for the archiving and retrieval of controlled documents from offsite storage.
• Will update databases to track lot status and other information and to generate reports on a scheduled basis.
• Performs detailed audits of Manufacturing batch documentation and resolve any issues with the appropriate personnel
• Monitor documentation error rates of different departments by utilization of a database which will be updated on a daily basis
• Prepare and perform verifications for various Release office functions such as intermediate product release, label authorization, and distribution release
• Communicate effectively with multiple departments in order to provide customer service.
• Responsible for training QA specialists.

Knowledge, Skills, and Abilities:

• Ability to keep neat, accurate and complete records and logs.
• Must be proactive, results oriented, with a strong attention to detail.
• Self-starter with good work ethics and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. 
• Strong organizational, analytical, troubleshooting and problem-solving skills. 
• Ability to analyze details and perform structured decision-making on a daily basis. 
• Excellent verbal and written communication. 
• Must be able to read, write, and speak English. 
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. 
• Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, Access, etc.

Education and Experience:

• Associate’s Degree or Bachelor’s degree in the Science fields.  Bachelor’s degree is strongly preferred.
• Minimum of 5 years of Quality Assurance experience in auditing or document control is preferred.  Related cGMP industry experience desirable                                                          

Occupational Demands:

Must be able to work Monday – Friday, standard business hours of 8am – 5pm. 

The estimated pay scale for the Sr. QA Specialist role based in Vista, California, is $93,524.90-$140,287.35 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.

California Personnel Privacy Policy and Notice at Collection

Location: NORTH AMERICA : USA : CA-Vista:USVISTA2 - Vista CA-980 Park Center Drive-AC

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