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Quality Control Technician
2 months ago
Role Summary: The Quality Control Technician plays a vital role in ensuring the integrity of pharmaceutical products through rigorous testing and analysis.
Key Responsibilities:
- Conduct and assess a variety of assays within the Quality Control department, focusing on In-Process intermediates, drug substances, drug products, and stability samples in compliance with cGMP standards.
- Utilize advanced analytical techniques, including high-performance liquid chromatography (HPLC) and mass spectrometry, to perform biochemical assays.
- Interpret data effectively, troubleshoot assay failures, and resolve equipment issues while adhering to stringent cGMP documentation protocols.
- Support cycle development, performance qualifications, method transfers, and investigations into discrepancies or out-of-specification results.
- Collaborate with external teams to identify and implement improvements in technology and business processes.
Work Environment: This position is based in a laboratory setting.
Additional Responsibilities:
- Adhere to company policies and maintain a state of inspection readiness.
- Operate laboratory equipment, including glassware washers and autoclaves.
- Manage multiple priorities independently with minimal guidance.
- Conduct environmental monitoring and water sampling as required.
- Assist customers in support of departmental functions.
- Engage in the design and execution of departmental and cross-functional initiatives.
- Apply fundamental theories and technical principles to solve moderately complex issues.
- Initiate resolutions for Quality concerns by fostering effective interdepartmental partnerships.
- Act as a technical subject matter expert in support of departmental operations.
- Sign documents for activities as authorized by company policies and procedures.
- Uphold the company’s Core, Common, and Critical Competencies in all behaviors and actions.
Qualifications:
- Bachelor's degree in Life Sciences or a related field, with 2-3 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
- Hands-on experience with analytical techniques such as HPLC and mass spectrometry, coupled with strong communication skills for both verbal and written formats.
- Proven ability to apply scientific theories and principles in analytical or biological testing procedures.
- Demonstrated sound judgment and problem-solving capabilities.
- Ability to work under moderate supervision and prioritize tasks effectively.
Physical Requirements:
- Work within an office and laboratory environment.
- Ability to lift up to 25 lbs as necessary.
- Capability to sit, stand, and move within the workspace for extended periods.
- May require prolonged periods at a computer terminal.
Harvest Technical Services is committed to equal opportunity employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other protected class.
