Quality Assurance Associate

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."