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Glenmark Pharmaceuticals, Mahwah, NJ, USA – Job vacancy for Quality Assurance Associate – Apply now
Quality Assurance Associate
Position Description
Role / Position Title – Senior Associate, Quality Assurance
Department/Function – Quality Assurance
Country – USA
Region / City (within Country) – Mahwah, NJ
FLSA (Exempt/Non-Exempt) – Exempt
Overall Job Responsibilities
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.
- Preparation and review of Standard Operating Procedures for Quality department and review for other department’s standard operating procedure.
- Handling all internal Deviations, NCRs, CAPA, OOS/OOT and Change controls and ensuring proper investigation and CAPA implementation/closure as applicable.
- Tracking and trending of quality events.
- Handling of employee Trainings and records.
- Handling analytical method validations/ transfers.
- Review of Process validations and Bulk hold time study protocols and reports.
- Review of Stability data and Freeze thaw data protocols and reports.
- Review of artworks for new products/ existing products.
- Review of Annual Product Quality Review.
- Preparation and review of Quality Agreements.
- Review of Manufacturing and Analytical documents prior to batch release.
- Participating in Regulatory/Customer inspections.
- Participating in internal audits.
- Tracking and monitoring of PQC and DQRS communications.
- Handling of SAP related activities pertains to Quality.
Knowledge, Skills And Abilities
Education
- Bachler’s degree (or equivalent) in Science
Experience
- 1-3 years of experience in pharmaceuticals industry, preferably in Quality Department
Knowledge and Skills (Functional / Technical)
- Knowledge of FDA and DEA regulations
- Proficient with MS Office (Word, Excel, PowerPoint and Outlook)
- SAP or any other ERP system
Physical Demands And Abilities
- The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
- The noise level in the work environment is typical of that of an office
- Incumbent may encounter frequent interruptions throughout the work day.
- The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds
About Glenmark
Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve peoples’ lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.
Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.
Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.
BENEFIT HIGHLIGHTS
- Paid time off
- 401k plus company match
- Company paid health benefits
- Dental
- Vision
- Onsite access to company gym
- Corporate Discount Program
- Paid Employee Referral Program
- EAP – Employee Assistance Program
- Accident Insurance
- Critical Illness Insurance
- Commuter Accounts
- Short-Term Disability
- Life and AD & D Insurance
- Whole Life Insurance
- Pet Insurance and so much more!
This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.
Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
