QC Project Manager

Employer
Bachem
Location
Vista, CA, US
Posted
Aug 20, 2020
Ref
615700301
Discipline
Quality, Quality Control
Hotbed
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