Rangam consultants Inc.

Quality Assurance Specialist

Established in 1995, with offices in three continents, Rangam Consultants Inc. is a high-performing diverse supplier of enterprise-wide staffing, payroll and on-boarding services. We are a certified WMBE that has consistently grown year-over-year and have an excellent history of client retention. We are proud that our clients consistently rate us among their top 5 service providers.

An expert workforce and cutting-edge technology solutions allow Rangam to serve large clients nationwide. Our mature business processes have enabled us to successfully serve Fortune 500 corporations and the public sector
QA Specialist
Job Code: RCI-AMG-3638
Job Location:  Woburn (Massachusetts-United States of America)
Job Description:  Willing to work any shift (fixed shift; 1st: 6am; 2nd; 1:30pm and 3rd; 10pm), five days a week (M-F) and potential a 6th day (Saturday if needed).

Ideal Candidate- Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk (doc review), pass gowning certification, pass visual test to perform AQL, flexible to work different shift and managing multiple priorities at the same time.

Job Details: Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured.
Primary responsibilities of this position include:
- Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
- Ensures that facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
- Responsible for ensuring raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
- Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations.
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are immediately triaged, investigated and documented per procedures
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
- Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
- Alerts senior management of significant quality, compliance, supply and safety risks
- Perform AQL for Visual Inspection (must have successful passing results visual test before)
- Release of gases, cell banks and labels
- Oversight the Aseptic Processing filling and provide advice and guidance during the process
Functional Area:  Quality Control
Functional Role:  QA/QC Executive
Candidate Requirement
Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk (doc review), pass gowning certification, pass the visual test to perform AQL, flexible to work the different shift and managing multiple priorities at the same time..
Experience:  0 - 5 years
Qualification:  Diploma in Science with Bachelor of Science
Preferred Resume Format:  MS-Word
 
Rangam consultants Inc.
Aakash Mishra
270 Davidson Avenue Suite 103,
Somers Point, New Jersey
United States of America 8873

Phone: 908-704-8843
Fax: 877-388-1858 Website: http://www.rangam.com
Job Ad publication date: 11 Nov 2017