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QC Project Manager

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

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

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

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

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: Los Angeles