Job Listing Description

Local Quality Expert (Entry)

PDS Tech, Inc. is seeking a Local Quality Expert (Entry), in Berkeley, CA.

Responsible Subject Matter Expert provides technical support for clinical batch manufacturing which includes reviewing clinical batch production documents, providing QA evaluation of discrepancies Support implementation of respective global Quality initiatives, programs and regulations. Share best practices experiences within Quality function. 1-3 Years of Experience. 

Key Tasks: 
  1. Independently reviews, revises and approves clinical batch production documents (e.g. master batch records, Clinical Manufacture Facility's operational SOP, Change controls, Deviations etc.) and provides QA evaluation of discrepancies offering sound suggestions on improvement. 
  2. Trains internal customers/stakeholders on QAD relevant activities. 
  3. Supports internal and external inspections and audits. 
  4. Revises SOPs or other QA & Compliance documents. 
  5. Signs Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP). 
  6. Reviews and approves manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan. 

Qualification & Competencies: 
  • Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics. 
  • 6+ 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. 
  • 4 years of relevant experience in the biopharmaceutical industry 
  • with an emphasis in Clinical Manufacturing lot release in a GMP regulated industry. 
  • Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs. 
  • Previous work experience in a Clinical manufacturing setting 
  • General understanding of drug development process R & D area 
  • Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines. 
  • Proficiency in IT systems and software, e.g., MS Office and SAP 
  • 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. 

Job Number: 2010121608
Job Location: Berkeley, CA
Duration: 6 months
Input Date: 11/18/2020
Attention: Amy Kloeppinger
City, State: IRVING, TX 75062
Phone: 214/647-9600
800 Phone: 800/270-4737
Fax Phone: 214/647-9630

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