A leading Dietary and Nutraceutical company in South Plainfield New Jersey 07080 is immediately looking for a Qualified In -process Quality Assurance Coordinator (First shift). The position directly reports to Vice President, Quality Systems &Regulatory.
This position is highly transparent and visible and provide direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. Candidates who reside nearer to Zip code 07080 would be highly desirable.
Details of job responsibility are as under: -
Areas of Responsibility (Quality and Safety)
Understand and assist compliances to FDA Regulations 21 CFR 111 and 117 covering all Sub Parts for food, dietary/ supplement Industry.
Undertake daily walk through of the facility and In-process operations
Execute and review the batch disposition process for raw materials, components, and finished products in accordance with specifications
Assist GMP/SQF/Organic/Kosher/Halal certifications and their follow up
Implementation of HACCP and Food defense requirements.
Assist and ensure compliance to FSMA/FSVP per regulations
Ensure Line clearance and support Environmental Monitoring Program
Undertake daily Batch record review and approval process
Review of Product specifications create Item Numbers/Lot Numbers & COA for Ingradients and finished products.
Finalize COA for all products and process that include Blending, sterilization, Jar filling and repackaging
Possess hands on expertise to Software’s for specification, testing and proper incorporation on COA
Undertake and assist Pick lists for finalization of Blend batches and alike
Assist in implementation of Organic Certification for Products and related processes.
Lead investigations for quality related issues through non-conformance and deviation systems, CAPA process timely.
Understand and implement Quality standards/metrics/SOPs effectively.
Assist convening Quality Meetings, drafting minutes and follow up.
Best drafting skills to cGMP/GDP /SOP and Document controls.
Undertake yearly Annual Product Review
Assist / lead internal/ regulatory audits as directed by Quality Management.
Assist implementation of Organic Certification to raw and finished products
Assist and undertake Vendors/ Supply Chain Management strategies
Assist with equipment qualification and process Validation as needed.
Provide oversight to the Calibration and Preventive maintenance process.
Provide and ensure all change control for Systems/process/Products/Documents in effect
Undertake timely complaint /investigations.
Implement trend analysis to various metrics to comply Quality and Safety.
Undertake Training programs to Quality/GDP/GMP/Food safety needs.
Liaise with Contract service agencies/Laboratories as directed.
Other projects as directed by Head of Quality
Follow company, Safety practices.
Work extended hours and occasional weekend/ overtime as needed.
Other duties as assigned
