Quality Control Specialist II (m/f/d)
$64,639–$103,464 year
HybridKundl, Tyrol, Austria
Job Summary
QC Specialist II responsible for leading investigations related to OOS/OOE/OOT, deviation and CAPA management, reviewing and ensuring integrity of analytical data (IPC, release, stability) in line with cGxP and data integrity requirements, preparing and evaluating stability plans and reports, qualifying analytical equipment, maintaining GMP-relevant documentation, monitoring KPIs/KQIs, serving as SME during audits/inspections, and supporting digital quality control initiatives with systems such as GLIMS, eLN, and Empower; role involves collaboration across functions and contribution to continuous improvement with a two-year fixed-term contract in Kundl, Austria.
Required Qualifications
- University degree in biology, chemistry, pharmacy, or a related scientific field, or equivalent experience in a pharmaceutical or manufacturing analytical laboratory
- Several years of experience in a GMP-regulated Quality Control environment, preferably within the pharmaceutical industry
- Strong knowledge of cGxP, data integrity, TQM principles, QC testing, sampling, and laboratory excellence standards
- Hands-on experience with analytical laboratory equipment, qualification activities, stability studies, and analytical documentation review
- Strong analytical mindset with sound risk management, quality decision-making, and problem-solving skills
- Ability to collaborate effectively across functions, manage priorities, provide feedback, and contribute to continuous improvement
- Good knowledge of laboratory IT systems and applications, with awareness of information management and data security requirements
- Proficiency in English and German, both written and spoken
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