Sr. QA Specialist

GRIFOLS, S.A.•Oceanside, CA

3d•$93,525 - $140,287•Onsite

About The Position

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.

Requirements

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.
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

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.