• Support Operations by analyzing raw materials, intermediate batches, packaging and finished products as required.
• Responsible for trouble shooting and investigating out of specification results.
• Perform analytical testing on all incoming Raw Materials as per our reduced testing program as well as an annual full testing using USP/NF, FCC, Pharmacopoeia and companies methodology.
• Responsible for the disposition of raw materials, intermediates, batches, and finished products in a timely manner.
• Data entry of test results.
• Investigate out of specification results.
• Support method and/or product transfer and NPI activity as necessary.
• Preparation, documentation and maintenance of test solutions and standards.
• Maintain, calibrate, and validate laboratory equipment.
• Ensures that GMP, Quality, Health & Safety are considered in all aspects of role.
• Perform other duties as directed by QC Specialist or QC manager.
• Routine testing of raw material, bulk batch, packaging and stability samples.
• Authority to notify Operations in manufacturing or filling processes if a problem affecting the quality of the product has been discovered.
• Authority to initiate investigations in quality related issues.
• Authority to quarantine bulk or finished products if the need arises.
• Investigate out of specification and out of trend data, and recommend CAPA.
• Participate on cross-functional teams
• Comply with all safety procedures and policies
• Participate in Operational Excellence initiatives and programs
• Incorporate Lean Sigma/ Lean Lab principles into ways of working
• Flexibility to work extended hours (including weekends) to achieve results as needed.
SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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