Quality Control Associate
4 weeks ago
Responsibilities:
- Execute and coordinate routine and non-routine testing in Quality Control (QC) for bulk drug substances and drug products within a multi-product facility.
- Perform fundamental operations independently, such as biochemistry, drug product device testing, UV-Vis absorbance, gel electrophoresis, pH, and osmolality, following adequate training.
- Provide internal support including stocking consumables/materials, updating controlled SOP binders, discarding expired reagents, and recognizing/reporting process and equipment anomalies.
- Deliver high-quality analytical results within specified timelines and with accuracy ("right the first time").
- Document work in compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Adhere to established regulations and site-specific cGMP standards.
- Report abnormalities and deviations in a timely and accurate manner.
- Follow safety standards, identify unsafe situations or habits, and escalate as necessary.
- Maintain work production areas according to predefined standards (5S).
- Maintain compliance with training requirements and train other technicians and associates on operations upon completion of trainer qualification.
- Represent QC operations on cross-functional root cause analysis teams for deviations, Corrective and Preventive Actions (CAPAs), and risk assessments.
Skills:
- 3-5 years of industry experience.
- GMP experience is highly preferred.
- Strong interpersonal and communication skills (both written and oral).
- Demonstrated customer focus and ability to interact with various departments and levels.
- Ability to work independently and as part of a team to meet departmental and facility goals.
- Capable of working across functions to achieve common objectives.
- Strong attention to detail and focus on the execution of tasks.
Education:
- Bachelor’s degree in Biology or Life Sciences required.
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