QA Specialist - I

San Dimas, CA


Contract Duration: 6-18 months


Rate: Negotiable


Salary: NA $1.00


Responsibilities:

• Excellent employment opportunity for a QA Specialist - I in the San Dimas, CA area.
• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
• Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
• Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.
• Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
• Normally receives general instruction on routine work, detailed instructions on new assignments.

• BS/BA degree and a minimum of 2-3 years of relevant experience. QA experience preferred.
• Educational background in the sciences (Engineering, Biology, Chemistry).
• Must have an understanding and application of QA principles, concepts, industry practices, and standards.
• The ideal candidate we are looking for should have previous experience in pharmaceutical (ideally bulk processing and aseptic processing) and/or investigations experience
• Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
• With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action.
• Normally receives no instruction on routine work, general instructions on new assignments.
• Strong verbal, technical writing, time management and interpersonal skills are required.
• Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
• Must have strong writing skills to present findings in a clear and concise manner.