Quality Assurance Associate

Job Description

Job Description

About the Job

This position is responsible for ensuring quality systems work properly and in compliance with Good Manufacturing Practices and USFDA / NABP Guidelines.

Job Responsibilities

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Carrying out Quality Inspection of all incoming batches including return goods per current approved procedure.
• Pull out data loggers from the batches, download the data, enter the temperature entries in SAP and generate Data logger Communication Form for each batch.
• Forward all DLC Forms to respective manufacturing sites for their review and disposition recommendation.
• Upon receipt of the disposition recommendation from the site, keep DLC forms/COA in batch/PR&D dedicated folder.
• Perform transportation studies per approved protocol.
• Support in investigations related to QA and warehouse operations.
• Handling of damaged, rejected, recalled drug product.
• Handling of destruction of pharmaceuticals drug products.
• Support regulatory inspections (FDA, DEA, VAWD/NABP, NJDOH etc.)
• Ensure US Allentown distribution warehouse is in compliance following CGMP’s.
• Handle/carry out other QA departmental activities/projects as assigned by supervisor.

Qualifications

Education

• BA/BS or equivalent work experience.

Experience

• Minimum 1 to 5 years of related experience in the pharmaceutical industry, preferably in QMS and Warehouse Quality compliance.

Knowledge and Skills

• Excellent communication skills, both written and verbal
• Knowledge of Pharmaceuticals Warehouse activity will be preferred
• Knowledge of GMP and regulatory requirements for the pharmaceutical industry.
• Strong proficiency with applicable computer software, SAP and MS applications.

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 workday.
• The incumbent 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

Compensation and Benefits

Salary Range - $55,000 – 70,000 USD

The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location.

Benefits include:

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s 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.

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 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.