Quality Assurance Associate - Controls

Controlled Substance Manager

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 fulfillment 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

Experience

Knowledge and Skills

Physical Demands and Abilities

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 :

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.