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Quality Assurance Machine Operator

Location:
Wrightstown, New Jersey, United States
Salary:
45000
Posted:
October 16, 2016

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SUNIL PATEL ** Canter Place

Chesterfield, NJ -***15

(732) ***–****

acw2y9@r.postjobfree.com

PROFILE

About 10 years of experience in pharmaceutical Quality Assurance and manufacturing.

Handled Tablet/Capsule/Softgel parameter tools like Friabilator, Disintegrator, Vernier Caliper, Hardness Tester, Balances, and Humicap.

Assist in development process of bi-layer tablet with all quality standard.

Supervised manufacturing of Tablet and Capsule batches.

Sampling of raw materials and finished blends and finished products.

Basic knowledge of Safety, Purity, and Efficacy from cGMP/FDA.

Ability to work simultaneously on diverse products/projects individually and in a team environment.

Fast learner who likes to do challenging tasks, ability to develop new ideas, finish routine tasks in timely fashion.

Necessary Mathematical skill for calculation and problem solving.

Sound knowledge of computer tools like MS Office.

PROFESSIONAL WORK EXPERIENCE

Quality Assurance Associate

Aspire Pharmaceuticals, Somerset, NJ November 2013 – Present

Daily Monitor and record Pharmaceutical Environmental factors like temperature, humidity, and air pressure.

Check raw material with its name, number, and approved COA at the weighing stage.

Verify calculations at various stages of manufacturing processes.

Inspect and give approval of room and /or line clearance before processing any activity through specified SOP.

Cleaning verification of encapsulation machine as per SOP.

Inspecting tooling like Dye roll, Sagement, Conveyer belt, and Hooper.

Evaluate Softgel at In-process, start, middle, and at the end for weight variation, thickness, disintegration, and tooling/imprint with established standard of BMR/Protocol.

Review of finished batch manufacturing record.

Coordinate with in manufacturing facility from QA, QC, Engineering to manufacturing departments regarding any issues based on cGMP.

Create samples for new raw materials to be tested and release raw materials once the Lab Results are verified

Senior Quality Assurance

NBTY, Inc., South Plainfield, NJ December 2010 – September 2013

Reviewed SOPs, batch records and test techniques.

Ensured GMP compliance for raw materials and components disposal.

Provided assistance during product failures and complaints.

Reviewed, approved and tracked closure of deviations, non-conformances, OOS and corrective actions.

Assist in deviation process &/or CAPA as per appropriate SOP &/or cGMP.

Provided research support and reminder of non-conforming materials.

Conducted Internal and customer audits to meet cGMP.

Released product record to be reviewed and endorsed by QA Manager.

Provided training to new Quality Assurance Associates

Quality Assurance Associate

NBTY, Inc., South Plainfield, NJ March 2004 – December 2010

Check Quality of Dietary Supplements and blends across various departments.

Process checks on tablets/capsules, and physical characteristics.

Prepare SOP’s and general working instructions.

Ensure the documentation as per FDA requirements.

Perform testing and data validation.

Maintain appropriate archival of QA documentation (e.g. test cases, test results, test data, etc.)

Machine Operator

Strides, Inc., Somerset, NJ August 2001 – March 2004

Responsible for the operation of various types of processing and test equipment in environmentally controlled areas per

Standard Operating Procedures. (Ex. High speed automatic encapsulators and automatic Softgel presses.

Check shape, weight, and seal check of Multivitamin Softgel.

Monitor cycles and review data to ensure requirements are met and complete all associated documentation.

Personal responsibility for following safety rules, SOPs and cGMP

EDUCATION

Bachelor of Science in Herbal Medicine, Gujarat Ayurveda Medical School, India

Associate of Science in Medical Laboratory Technology, Nidan School of Medical Technology, India

Associate of Arts in Software Engineering, Bureau of Information Technology Studies, India

REFERENCES

Provided upon request.



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