Quality Assurance Associate at Norwich Pharmaceuticals Inc

Morristown, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Aug, 26

Salary

0.0

Posted On

11 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Batch Record Review, COA Review, COC Review, CAPA Tracking, KPI Tracking, cGMP Quality Systems, Process Improvement, Pharmaceutical Quality Assurance, Technical Writing, Time Management, MS Word, MS Excel, MS PowerPoint, MS Vision, MS Access

Industry

Pharmaceutical Manufacturing

Description

SUMMARY OF POSITION The Associate US Quality is a member of the US Quality department. The Associate is primarily responsible for supporting the Non- Sterile Third-Party Quality all associated documentation requirements for the Alvogen Inc. and the Almatica Pharma Inc. business units. ORGANIZATION STRUCTURE The Associate Non-Sterile TPQ reports directly to the Associate Director, Third Party Quality . There are no reports, direct or otherwise, to the Associate Non-Sterile TPQ. RESPONSIBILITIES Primary responsibilities of this role include the following: 1. Perform Batch Record Reviews, review of COAs, COCs for Product Release for commercial products. 2. Identification of any deviations if not previously identified by CMOs during the records and bring it up with the management. 3. Track the CMO CAPAs 4. Support the QMS team by tracking the KPIs for the assigned CMOs . 5. Identify and improve processes. 6. Keep abreast of industry regulations, guidance’s, guidelines, and trends. QUALIFICATIONS Position requires the following education and qualification prerequisites: 1. Bachelor’s Degree in a Science related field with 1-4 years related experience in pharmaceutical industry. Familiarity with post-filing and preapproval activities (validation and commercial readiness) is desired. 2. Knowledge of cGMP quality systems, guidance documents, industry standard concepts, practices, and procedures is desired. Experience at a generic drug company is preferred. 3. American Society for Quality (ASQ) Certification or equivalent is desired. 4. Excellent oral and written communication skills. 5. Proficiency in MS Word, Excel, PowerPoint, Vision, and Access. 6. Ability to utilize software and customized programs (EQMS, EDMS, and LMS) to meet business needs. 7. Good organization, planning and time management skills required. 8. High attention to detail. 9. Able to work independently and with others. 10. Self-motivated. Physical Demand Factors 1. While performing the duties of this job, the Associate US Quality is required to sit and work at a computer for extended periods of time. 2. Is regularly required to talk and listen. GMP DECISION-MAKING AUTHORITY As directed by Quality management, independent decision-making activities will be performed by the Associate Non-Sterile TPQ for the batch release process and bring any anomalies to the attention of the area management. “An Equal Opportunity Employer, including disability/vets.”

Responsibilities

The Associate is responsible for supporting Non-Sterile Third-Party Quality documentation, including batch record and COA reviews for product release. They also track CMO CAPAs and KPIs while identifying process improvements to ensure regulatory compliance.