Knowledge/Skills requirements
Must possess knowledge of FDA 21 CFR Parts 210/211/111 and current Good Manufacturing Practices (cGMP)
Working knowledge of Microsoft Office and other computer operations.
Excellent analytical and problem-solving skills and written and verbal communication
To coordinates lead personnel for manufacturing Process.
Individual contributor which performs all paper batch record preparation that is related to manufacturing of dietary supplements product in a multi-product facility
Working knowledge of enter data into applicable spreadsheets/databases and Master Formula.
Education and physical requirements
Minimum High School Diploma Program including biological and physical sciences and 8 -10 years of experience or Bachelor of Science degree in scientific field, 3-5 years of experience working in the Pharmaceutical/Personal Care Industry.
Excellent analytical and problem-solving skills and written and verbal communication.
Ability to work in a fast pace environment and to value the importance of teamwork. Physical hard work Demands.
Detailed oriented with the ability to follow instructions.
Job Responsibility
- Monitors suppliers and manufacture vendors to ensure ingredients, components and services meet regulatory requirements and internal quality standards
- Collect and review suppliers’ documentations, certificates, registration records, etc. to verify if they meet suppliers’ qualification programs based on risk factors
- Trend and monitor supplier performance and track vendor liability, identify high-risk suppliers and act as a bridge between internal procurement and quality department
- Prepare, review, submit technical dossiers and applications to certification bodies (Organic, Kosher, Halal, Non-GMO Project, SQF, etc.)
To cross-check conformance to the SOP requirement of Line clearance and give Line clearance for unit operations to make sure that they are set free of defects.
To exercise an effective control over secured "Document Control" including storage, locations, binders, distribution and archiving of all GMP/ISO documents.
To assist timely releases of finished products by taking proactive steps including tracking status of batch records, testing of external Labs, as applicable, review and correction in Batch records
Take round to facility at least twice in day to ensure GMP and workplace safety by following inhouse SOPs and to bring any non-conformance to Vice-president and QA Manager attention.
To assist the Management in audit compliance including follow-up actions, documentation and preparation of response to audit observations.
To assist in completing tasks such as investigation of complaints, self-inspections including completing actions emerging during these processes.
To check on the verification status of instruments and equipment every day to make sure that they are verified and / or calibrated on time as per the defined frequency.
Review environment monitoring data on daily basis. Document any temperature excursion.
To archive tested samples and reserve samples of dietary components in the designated reserve sample area once a week.
To complete Manufacturing paper work to ensure that all data is accurate and has authentic traceability.
To report OOS events and any incident that impacts quality, output and efficiency to QA Manager.
Assist VP to purchasing of raw materials whenever required.
To conducts observing cleanliness of the Manufacturing facility, benches and equipment and follow Good manufacturing practice. (GMP).
Work on additional duties whenever assigned by Vice-President.
Job Type: Full-time
Pay: $17.00 - $20.00 per hour
Work Location: In person
