• 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 and the company 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, Healthy & Safety are considered in all aspects of role. Perform other duties as directed by QC Specialist or QC manager.
• ***MAIN task will be Data Review***
• 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 an 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 archive results as needed.
• Science degree in applicable scientific studies or equivalent experience (BS Degree preferred).
• Working laboratory experience, preferably with FMCG experience.
• Working knowledge of CompanyQuality standards, GLP and GMP requirements.
• Working knowledge of validations, calibration systems, and instrumentation.
• Working knowledge of applicable Company policies and procedures.
• Problem solving/continuous improvement skills.
• Development skills in coaching, interpersonal communications, team building and training facilitation.
• High level of computer literacy. Ability to interact with all levels of the organization.
• Experience in writing, reviewing and revising SOPs.
• Excellent written and oral communication.
• Working knowledge of Microsoft Word, Microsoft Excel and Laboratory Information System (LIMS).
• Ability to work and succeed in a team based environment.
• Flexibility to work extended hours (including weekends) to achieve results as needed.
SRG 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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