Quality Assurance Specialist (Pharmaceutical)

SwiftScout; Germany (OH); On-site; USD 60,000 - USD 80,000; Part time

Job summary

A contract manufacturer in pharmaceuticals is seeking a Quality Assurance Specialist to manage and improve the QA system. This part-time role involves maintaining quality documentation, implementing EU GMP guidelines, and preparing for audits. Ideal candidates will have a Bachelor's degree in Chemistry or Biology, strong organizational skills, and good English proficiency. This is a parental leave replacement position with up to 30 hours per week.

Qualifications

• Bachelor's degree in Chemistry or Biology, or comparable training.
• Strong organizational skills and attention to detail are necessary.
• Good English communication skills and proficiency in MS Office.

Responsibilities

• Maintain and advance the Quality Assurance system.
• Create and maintain quality documentation and manage inspections.
• Implement EU GMP guidelines and support authority inspections.

Skills

Strong organizational skills

Meticulous attention to detail

Good English skills

Proficiency in MS Office

Education

Bachelor's degree in Chemistry, Biology, or comparable field

Completed training as a Medical Documentation Assistant, Pharmaceutical Technical Assistant, or Chemical Technical Assistant

Job description

Quality Assurance Specialist (Pharmaceutical) | Chemiker (m/w/d)

AMCAPHARM Pharmaceutical GmbH

Join AMCAPHARM Pharmaceutical GmbH, a contract manufacturer of pharmaceuticals for the German, European, and international markets, specializing in suppositories and liquids. This part-time role (up to 30 hours) is a parental leave replacement within Quality Assurance Management. The specialist will be crucial in maintaining and advancing the Quality Assurance (QA) system, including quality risk management, and actively participating in implementing the EU GMP guidelines. Day-to-day tasks involve creating and maintaining quality documentation, qualifying equipment and suppliers, and managing inspections and audits from authorities and customers. The ideal candidate holds a Bachelor's degree in Chemistry or Biology (or equivalent qualification/training) and possesses strong organizational skills, meticulous attention to detail, and a high sense of responsibility for quality standards. Good English skills and proficiency in MS Office are required to handle correspondence and documentation effectively.

Education

Bachelor's degree in Chemistry, Biology, or comparable field; alternatively, completed training as a Medical Documentation Assistant, Pharmaceutical Technical Assistant (PTA), Chemical Technical Assistant (CTA), or comparable qualification.

Experience

• Professional experience in monitoring and developing QS systems (Quality Assurance Systems)
• Experience in implementing EU-GMP guidelines
• Experience in preparing for and supporting authority inspections and customer audits

Additional

• Part-time position (up to 30 hours); Parental leave replacement.