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Quality Assurance Associate - Controls

Quality Assurance Associate - Controls

Glenmark Pharmaceuticals Inc.Allentown, PA, US
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Job Description

Job Description

About the Job

This position is responsible for handling of Controlled Substance related activities and QMS.

Job Responsibilities

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

  • Handling of receiving and storage of controlled substance at Glenmark Allentown, PA location per current Procedures and DEA regulations
  • Coordinating with Sales and Marketing for fulfilment of customer orders, processing, shipping and documentation per current DEA regulations,
  • Handling of controlled substance periodic inventory counts
  • Handling destruction of controlled substances per current procedures and DEA regulations
  • Ensure all the activities related to controlled substances are carried out per current DEA State and Federal regulations.
  • Maintaining Deviations, Investigations, CAPA, Change Controls, Protocols – Trackers-Logbooks.
  • Issuance, Retrieval and Archival of Logbooks
  • Preparing SOPs related to Quality Assurance along with evaluation of SOP Quizzes.
  • Preparing Master SOP Index & Format Index
  • Ensuring proper documentation control activities are being followed per cGMP requirements
  • Review and maintaining existing Quality System and ensuring compliance to Agency Regulations / cGMP expectations
  • Maintaining employee training and ensure training is carried out and completed per current procedures and regulations
  • Carrying out Quality Inspection of all incoming batches per current approved procedure
  • Support regulatory inspections (FDA, DEA, VAWD / NABP, PADOH etc.)
  • 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, handling controlled substance, QMS, Warehouse compliance and Inspection activity.

    • 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 and warehouse 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 and warehouse
  • 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

    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.

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    Quality Quality Control • Allentown, PA, US