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QA Specialist I (Document Control)

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.  
Bachem. Leading Partner in Tides 

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

Your Responsibilities

The Quality Assurance Specialist I (Document Control) fulfills a critical role for Quality Assurance. The primary function of this individual will support all activities related to the Document Control function, including the review and release of SOPs, Forms, Specifications, Batch Records, Plans, Protocols, Reports, etc. through Master Control.

This individual will support record management ensuring that the site stays in compliance with FDA and international regulatory requirements.

 

Your Tasks

Review and process all submitted documents through Master Control System in a timely manner, meeting monthly, quarterly and annually department goals

Issue logbooks, active and retired documents as required to meet department goals

As necessary, perform scanning of completed GMP documentation (Batch Records, QC Data compile TSE certificates for creation of RMSS certification)

As necessary, upload CofA and Retest certificates into Master Control

Perform Doc Control function in Master Control to support organizational needs

As required by the department, responsible for records management procedures and processes including documentation, record retention, archival and retrieval Including organization and update of the document room file as required

Create and revise product Master Labels in conjunction with corresponding specification creation/revision

Provide support for customer and regulatory audits; participate in responses to QA related observations

Implement improvements in quality systems and SOPs and QA owned documents

Represent QA in process improvement project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes)

 

Your Profile

A Bachelor’s Degree in Science or related field and a minimum of 1 years’ experience in a GMP setting or

Associates Degree in Science or related field and a minimum of 3 years’ experience in a GMP setting or equivalent experience

Minimum of 1 years’ work experience in a Document Control function

Ability to collaborate cross-functionally between departments to provide effective support and ensure timely execution of associated tasks

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

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

Communicate effectively and ability to function well in a team environment

 

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.