Overview
QA Specialist I Jobs in Barceloneta, PR at The Dako Group
Job Title: QA Specialist I
Duration: 1 Year Contract
Location: Barceloneta, PR (100% onsite)
Schedule: 1st or 2nd Shift (Must be available for any shift, including OT weekends based on business needs)
Payrate: $25/hr to $28/hr
Work Environment
- Team environment
- Batch Record Review area
Overtime – Yes
Interview Process – 1 Round (Onsite)
Required Skills, Experience, Education
- Bachelor’s Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
- Knowledge and experience in manufacturing of biotechnology products and GMPs is needed, and in aseptic processing is preferable.
- Experience working in highly computerized Operations environments– 1 Year
- Experience working in a Biotechnology Manufacturing Plant in areas of quality, or manufacturing – 2 Years
- The candidate must be proficient in the English language.
General Position Summary/Purpose
Job Responsibilities:
- Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
- Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).
- Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.
- Evaluate all deviations documented in batch records and determine the need for a corrective action.
- Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.
- Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.
- Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.
- Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product.
- Enter required batch information into the lot restriction management system.
- Assemble the batch record review package and label per the approved retention procedures.
- Prepare reports including Right the First Time, Release Cycle Time and Regulatory Audits requests. Revise procedures as required.
- Generate lot lists for the Product Quality Review.
- Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.
- Act as contact person for projects as required.
- Demonstrates accountability and responsibility of EHS performance and compliance.
- Creation and removal of QA Hold condition in SAP system.
Title: QA Specialist I
Company: The Dako Group
Location: Barceloneta, PR
Category:
