
Senior Quality Control Specialist
3 days ago
Quality Assurance Specialist
About the Role:This is a critical position within our organization's quality control team. The ideal candidate will be responsible for developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and guidelines.
The successful applicant will contribute to our commitment to quality risk management by tracking, interpreting policies, managing site complaints and collaborating with operating entities to provide process analysis oversight.
They will be relied upon to ensure that quality assurance programs and policies are maintained and modified regularly to meet company goals.
One of the key responsibilities will be to foster uniform standards worldwide and share best practices, contributing to the achievement of our company mission globally.
Key Responsibilities:- Perform analysis on QC samples (raw material, in-process tests, intermediates and finished product) in accordance with Current Good Manufacturing Practices.
- Adhere to good laboratory practices and maintain housekeeping standards.
- Assist in generating and maintaining quality procedures and reports.
- Facilitate laboratory investigations and support associated product investigation.
- Participate in initiatives focused on Right First Time, Continuous Improvement and 5S.
- A third-level qualification in Science or Engineering is preferred.
- Some experience working in a QC laboratory environment.
- Demonstrate proven experience with analytical techniques including bioassay/potency testing, ELISA, blotting, flow cytometry assays, PCR and molecular biology techniques.
- Excellent interpersonal and communication skills.
- Detail-oriented with quick decision-making abilities and self-motivation, along with strong problem-solving skills.
- Experience in quality control in a biotech, pharmaceutical or bio-pharmaceutical manufacturing environment.
- Knowledge of computer applications, including MS Office, Excel, Softmax and Laboratory Information Management System (LIMS).
- Mammalian cell culture experience.
- Skills in aseptic techniques and sampling handling.
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