Senior QC Scientist

Main Responsibilities:

• Manage QC test samples, including in-process, release, environmental monitoring, drug substance, and excipient samples.
• Oversee stability sample management to ensure proper storage, tracking, and testing schedules.
• Maintain regulatory retention samples and reference samples in compliance with applicable requirements.
• Ensure accurate documentation and traceability of all sample management activities.
• Support laboratory operations by coordinating sample receipt, storage, distribution, and disposal.
• Ensure all QC activities are conducted in compliance with cGMP, data integrity, and EHS requirements.

About You:

• Bachelor's Degree or higher in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.
• 3–5 years of experience in the biotechnology, biopharmaceutical, or pharmaceutical industry.
• Strong understanding of the drug development lifecycle and quality control processes.
• Solid knowledge of cGMP requirements and a strong quality and compliance mindset.
• Familiarity with global regulatory requirements and guidelines, including FDA, EMA, NMPA, ICH, WHO, USP, Eur. Ph., and ChP.
• Good understanding of regulatory submissions, including IND/IMPD, NDA, and ANDA filings.
• Strong organizational, documentation, and communication skills.
• Ability to work effectively in a fast-paced and regulated environment.

Pay: $4,500.00 - $6,500.00 per month

Experience:

• Pharmaceutical: 3 years (Preferred)
• GMP/GDP: 3 years (Preferred)
• LIMS Set-Up: 3 years (Preferred)
• QC/QA: 3 years (Preferred)
• QC test samples: 3 years (Preferred)

Work Location: In person