Description

JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process development, downstream process development, analytical services. The company also provide therapeutic protein drug cGMP manufacturing, from GLP IND to clinical phase manufacturing. There is a collaboration opportunity for clinical phase III and commercial stage cGMP manufacturing.

Requirements

Duties and Responsibilities:

• Manage document management in the EDMS System.

• Enter and assign training in the LMS System.

• Manage document product lot numbering system and labeling.

• Organize files and cabinets and label them appropriately.

• Provide QA evaluation of discrepancies, offering suggestions for improvement.

• Collaborate with external groups.

• Support internal and external inspections and audits.

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

• Manage the Quality System records storage and archival processes.

• Manage vendor qualifications.

• Manage the document control function, ensuring documents are initiated, reviewed, revised, filed, and archived in a timely and compliant manner.

• Perform other Quality System duties in support of the Quality Assurance function as needed.

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

• Serve as the company Training Coordinator to initiate, monitor, and record training assignments and completions for all personnel. Maintain metrics and routinely report training status to executive management.

• Monitor risk management activities.

Qualifications/Experience:

• Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology,

chemistry, or pharmaceutics.

• 2 years of related experience in the biopharmaceutical industry with an emphasis on

Document Control, Quality Control, Engineering, or Manufacturing in a GMP regulated

industry, or an equivalent combination of education and experience.

• Previous work experience in a GMP environment and exposure to manufacturing records,

testing reports, and SOPs.

• Knowledge of GMP regulations and an understanding of FDA and other regulatory

guidelines.

• Proficiency in IT systems and software.

• Proven ability as a team player.

• Strong analytical and problem-solving skills.

• Ability to professionally express views and opinions.

• Good listening skills and the ability to accept conflicting points of view.

• 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, focusing on developing the best team and delivering results

in line with expectations."