QC Project Manager

Vista, CA, US
Aug 20, 2020
Quality, Quality Control
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
Your Responsibilities

The Quality Control Project Manager fulfills a critical role in cGMP operations and plays a crucial role

i in active pharmaceutical ingredients (APIs) manufacturing operations. This individual will act as a

project manager in executing special projects such as validation and qualification studies, method

t transfers, API release, stability study designs and other department related technical studies and

continuous improvement projects. The Quality Control Project Manager should have full knowledge in

compliance, deviations, investigations, Out-of-Specifications (OOSs) and implement corrective action

and preventive actions (CAPAs).

Your Tasks
  • Write protocols and final reports, standard operating procedures (SOPs), and reports in compliance with current industry standards and regulatory requirements
  • Ensure the quality and integrity of data generated for each project by verifying documentation is complete and accurate, and all data documentation follows SOP requirements
  • Design and implement study plans and protocols to complete required assignments, and draw conclusions based on data generated
  • Support, implement and ensure compliance of all QC department policies and activities
  • Ensure compliance with all regulatory agencies through documentation, audits and corrective actions
  • Perform investigations related to QC with respect to data analysis, trend charts preparation, as requested by the QC Department
  • Review API release test data for completeness and accuracy as necessary
  • Provides timely responses to internal and external inquiries
  • Support and assist in internal/external inspections and audits
  • Contribute to GMP systems improvements
  • Apply knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) on a daily basis
  • Provide guidance for the review and disposition of deviations; investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent reoccurrences
  • Coordinates API release and stability studies as required
  • Lead weekly meetings providing timely updates on the status of projects with QC management
  • Provide the necessary drive and supervision for the department to meet the required timelines for method validation studies, technical studies, and other department projects
  • Ability to work and communicate with different associates within the company to ensure timely completion of assignment projects
  • Contribute to improvement in laboratory operations to increase efficiency and cGMP compliance

Your Profile
  • Bachelor's Degree with a minimum of 7 years of industry experience in a GMP/GLP environment
  • Strong knowledge of cGMP/GLP/GDP, USP/NF, ICH guidelines and FDA regulations
  • In-depth knowledge and understanding of Analytical Chemistry, including USP compendial testing
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint and Statistical and graphing software knowledge
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

l looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

Nearest Major Market: San Diego