Quality Assurance Associate (GMP / Aseptic Manufacturing) – 6 Month Contract
🏢 Multinational specialty biotechnology company
A multinational specialty biotechnology company is currently seeking a Quality Assurance Associate to support their aseptic manufacturing operations at their site in Bern.
This is a 6-month contract position offering the opportunity to work within a highly regulated pharmaceutical manufacturing environment and contribute to ensuring GMP compliance and product quality.
Key Responsibilities
* Provide QA support and guidance to aseptic manufacturing operations and microbiological laboratories
* Ensure compliance with GMP requirements within production processes
* Review and verify manufacturing documentation and production steps
* Participate in process reviews within aseptic manufacturing
* Support training and (re)qualification of production personnel
* Provide QA oversight during manufacturing activities and assist with risk assessments and compliance questions
* Manage deviations related to aseptic filling, including:
o Initial deviation assessments
o Supporting investigation strategies
o Reviewing technical assessments
o Supporting definition of corrective and preventive actions (CAPAs)
* Review investigation reports in German and English, ensuring compliance and appropriate risk evaluation
* Support internal and external inspections related to deviation management
* Assist with the review of procedural and quality documentation
Qualifications & Experience
* Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific field (Bachelor, Master, or PhD)
* Experience or knowledge of GMP within the pharmaceutical or biotechnology industry is advantageous
* Strong analytical thinking and problem-solving abilities
* Ability to review and critically assess technical documentation and reports
* Strong communication and teamwork skills, with the ability to interact across different organizational levels
* Ability to manage multiple tasks and changing priorities in a fast-paced environment
* High level of independence and initiative
Maybe not for you, but for someone else?
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