JOINN Biologics is a contract manufacturing service company, located in Richmond CA. 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
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:
• Review and approve manufacturing batch records, standard operating procedures (SOPs),
sample tables (STs) and laboratory control records and associated records, specifications,
sampling plan, Inspection Plan.
• Review and Disposition of Incoming Raw Materials
• Inspection of Incoming Raw Materials
• Review of supplier raw material changes
• Compiling, reviewing, and approving cGMP production lot files, including the Test
record Sheets TRS, Batch Production Records, associated records, specification,
sampling plan, QC reports and sampling plan.
• Provide QA evaluation of discrepancies offering suggestions on improvement.
• Collaborating with internal partners in Quality Assurance (QA), Quality Control, and
• 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 product for use in production.
• Sign Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required
to be executed by an authorized person (AP).
Manage the Quality System records storage and archival processes, assist in the record
keeping development and tracking of critical quality processes such as CAPA,
Complaints, Internal/External audit findings, and Non-Conforming Reports.
• Support the document control function as needed ensuring documents are initiated,
reviewed, revised, and filed and archived in a timely and compliant manner.
• Perform other Quality System duties in support of the Quality Assurance function as
• Assist with and may be assigned lead role on special projects with considerable
• Monitor risk management activities.
KNOWLEDGE, SKILLS & ABILITIES:
• Must possess strong technical and analytical understanding of Biologics Manufacturing
• Ability to clearly communicate compliance strategy and rationale via oral and written
• 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
• Proficiency in IT systems and software.
• 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 organizational skills with attention to detail.
• Ability to navigate different personality styles in a large, complex organization in a
• Ability to juggle multiple priorities.
• Strong leadership principles and deliver result in line with expectations.
• Bachelor’s degree in a scientific and/or technical discipline related to biology,
biotechnology, chemistry or pharmaceutics.
• 1+ years of related experience in the biopharmaceutical industry with an emphasis in Lot
Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP
regulated industry or equivalent combination of education and experience.
• Previous work experience in a GMP environment, exposure to manufacturing records,
testing reports, material release, test records and SOPs.