Sr. QA Specialist

2 weeks ago

San Pablo, United States 153136 JOINN Biologics Full time
Job DescriptionJob DescriptionDescription:

JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.

SUMMARY:

The QA Associate will be responsible for the overall strategy and oversight of JOINN Biologics Quality and Compliance for API and final product. This candidate will be writing protocols and must have strong communication, technical writing, and statistical analysis skills.

Duties and Responsibilities

· Tracks and investigates Deviation, CAPA, and Change Control.

· Manages the Quality System such as, tracking and archival of Changes, CAPA, Complaints, and Non-Conforming Reports.

· Supports customer project teams and efforts in continuous improvement at JOINN Biologics.

· Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.

· Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems.

· Interprets regulations and guidelines critical for advancement of QA systems.

· Independently leads compliance activities in CAPA, Change Control, and Deviation quality systems.

· Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives.

· Accountable for decisions and results that ensure timelines are met.

· May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression.

· May support and contribute to the direction and decisions of JOINN Biologics project teams.

· Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.

· Collaborating with internal partners in Quality Assurance (QA), Quality Control, Facilities and Supply Chain,

· Support internal and external inspections and audits.

· Support and execute improvements and troubleshoot manufacturing and QC operations.

· Create and revise SOPs or other QA & Compliance documents.

· Provide technical input to reject starting materials, packaging materials, and intermediate, components or bulk products, and drug products for use in production.

· Assist with and may be assigned lead role on special projects with considerable complexity.

· Reviews executed batch records.

· Monitor risk management activities.

· Other duties assigned.


Requirements:

· Must possess strong technical and analytical understanding of Biologics Manufacturing and testing.

· Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.

· Knowledge of scientific principles and concepts as they relate to Operations and GMP.

· Knowledge of CAPA, change control and deviation programs and requirements.

· Great team player who is collaborative and positive.

· Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.

· Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.

· Strong interpersonal, written/oral communication and problem-solving skills.

· Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.

· Proficiency in IT systems and software.

· Proven ability as a team player.

· Strong analytical and problems solving skills.

· Ability to professionally express views and opinions.

· Good listening skills and ability to accept conflicting point of views.

· Strong verbal and written communication skills.

· Strong organizational skills with attention to detail.

· Ability to navigate different personality styles in a large, complex organization in a professional manner.

· Ability to juggle multiple priorities.

· Strong leadership principles, focus on developing the best team and deliver result in line with expectations.


JOINN Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.

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