QA Assistant – Biotech

Black Swans Exist
Job Summary:
We are seeking a highly motivated and detail-oriented QA Assistant to join our Quality Assurance team. The QA Assistant will support the team in maintaining and improving quality systems, ensuring compliance with regulatory standards, and facilitating efficient QA operations. This role is critical to delivering safe and effective biotech products to our customers and partners.
Key Responsibilities:
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Documentation and Compliance:
- Assist in creating, reviewing, and maintaining quality documentation (e.g., SOPs, protocols, and batch records).
- Ensure records are up-to-date, organized, and compliant with regulatory standards (e.g., GMP, ISO).
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Audit Support:
- Prepare and organize materials for audits and inspections.
- Support the implementation and follow-up of corrective and preventive actions (CAPA).
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Quality Systems:
- Assist in monitoring quality metrics and preparing quality reports.
- Participate in root cause analyses for deviations and process failures.
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Training and Coordination:
- Provide support in employee training on quality standards and procedures.
- Collaborate with cross-functional teams to ensure quality objectives are met.
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Process Improvement:
- Identify opportunities for enhancing QA processes and propose recommendations.
- Contribute to the development and maintenance of quality policies.
Qualifications:
- Pharmaconomist (Farmakonom), or a related field.
- Experience in a quality assurance or quality control role (internships included) is preferred.
- Knowledge of regulatory standards such as GMP, GLP, and ISO is an asset.
- Strong attention to detail and organizational skills.
- Proficiency in MS Office and familiarity with quality management software.
- Excellent communication and interpersonal skills.
If you are passionate about quality assurance and eager to contribute to the development of innovative biotech products, we encourage you to apply.

Per Christensen
Managing Director & Co-founder
Per is the Managing Director and Co-founder of Black Swans Exist, a role he has held since the company's inception in June 2020. Based in Copenhagen, Per brings a visionary approach to the business, helping companies discover rare, high-impact talent, or "Black Swans," that drive extraordinary performance.
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