The Quality Assurance Manager is responsible for ensuring compliance with Current Good
Manufacturing Practices (CGMP) and Good Documentation Practices
(GDP). In addition, s/he will be responsible for ensuring efficient
and effective operational functionality of product by performing a
number of quality control processes, including, but not limited to:
conducting quality audits to ensure product quality; ensuring that
employees adhere to manufacturing, hygiene and sanitation
standards. The person in this position will implement, execute, and
enforce procedures by way of systems that will improve the overall
operations and effectiveness of the company by way of regulatory
compliance. Supporting production staff in problem solving efforts.
Following up and participation in continuous improvement projects.
· 3-5 years of CGMP experience in an FDA regulated industry.
· Experience in a CGMP environment is strongly preferred.
· Demonstrates strong interpersonal and communication skills (both written and oral), ability to interact with various departments and levels.
· Demonstrates ability to work independently and as part of a team, to meet department/facility goals; is also able to work across functions to achieve commons goals.
· Demonstrates strong attention to detail, and an ability to focus on detail of execution.
· Demonstrated ability to multitask and meet deadlines.
Bachelors in a scientific discipline or Business Administration.
· Adheres to GDP to ensure data integrity and traceability.
· Effectively implement and maintain the company’s standard operating procedures (SOPs).
· Understand test results and pursues clarification of out of specification (OOS) or out of trend (OOT) results.
· Responsible for ensuring that QC tasks are completed timely according to schedule, company policies, procedures, and test methods.
· Perform pre-operation inspection at the beginning of the production shift as well as pre-sanitation inspection at the end of the shift.
· Perform environmental monitoring (EM) of the production and testing areas.
Key Responsibilities include the following:
· Check HACCP critical control points and ensure proper corrective and preventive actions (CAPA) are taken to maintain food safety.
· Pre-op inspection of the processing line according to established procedures.
· Inspect incoming components and packaging materials.
· Pull retain samples from final product.
· Issue Batch Production Records per schedule.
· Authoring, reviewing of SOPs, validation protocols, and final reports.
· Monitor and evaluate internal production processes.
· Provide QA review of GMP documentation, including SOPs, production records, validation protocols, and validation reports.
· Must be able to wear company specified garments that assure cleanliness.
· Ability to work independently and as part of a team, to meet department/facility goals; is also able to work across functions to achieve common goals.
· Must exhibit high ethical standards and integrity.
Why Work Here?Panaceutics technology has revolutionized the ability to provide customized and personalized nutrition. Combined with advancements in nutritional science, Panaceutics’ unique manufacturing capabilities make the mass customization of targeted formulas for specific end user groups both simple and affordable. What sets Panaceutics apart is the ability to apply proprietary robotics and automation to customize these products to individual end user specifications. The art and science of personalization continue to advance quickly at Panaceutics with complete individualized, personalized nutrition as the ultimate goal.
Panaceutics is a world leader in personailzed nutrition.