Glenmark Pharmaceuticals Inc., USA
Quality Assurance Associate - Batch Release
Glenmark Pharmaceuticals Inc., USA, Allentown, Pennsylvania, United States, 18103
Quality Assurance Associate - Batch Release
Department: Quality
Location: Allentown, PA
START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3447873&source=3447873-CJB-0)
About the Job
This position is responsible for batch disposition and other quality functions in the pharmaceutical distribution center.
Job Responsibilities
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.
Review of Data logger communication (DLC) form along with data logger data, Packing slip and other related documents.
Review of Certificate of analysis, Batch records, Certificate of conformance and Investigation reports.
Coordinate with manufacturing sites for release documents and investigations.
Perform batch disposition including return goods per current approved procedure.
Coordinate with distribution center folks for handling of rejected batches.
Providing details of back order batches to all manufacturing sites on daily basis to keep track of batch release timeline and provide visibility for priority items.
Handling of temperature and humidity monitoring systems, including alerts and excursions, and coordinating with the Vendor for any requests or fixes.
Review weekly reports of temperature and humidity of the warehouse area
Handling of destruction of non-controlled products and controlled substance drug products.
Handling of Quality Inspection of all incoming batches per current approved procedure
Handling of drug product sample management.
Support in Investigations, Deviations, CAPA, Change Control related to QA and warehouse operations
Support regulatory inspections (FDA, DEA, VAWD/NABP, PADOH etc.)
Ensure US Allentown distribution warehouse is in compliance following CGMP-s
Handle/carry out other QA departmental activities/projects as assigned by the supervisor.
Qualifications
Education
BA/BS or equivalent work experience.
Experience
Minimum 3 to 5 years of related experience in the pharmaceutical industry, specifically in QMS and Batch release.
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.
START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3447873&source=3447873-CJB-0)
Department: Quality
Location: Allentown, PA
START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3447873&source=3447873-CJB-0)
About the Job
This position is responsible for batch disposition and other quality functions in the pharmaceutical distribution center.
Job Responsibilities
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.
Review of Data logger communication (DLC) form along with data logger data, Packing slip and other related documents.
Review of Certificate of analysis, Batch records, Certificate of conformance and Investigation reports.
Coordinate with manufacturing sites for release documents and investigations.
Perform batch disposition including return goods per current approved procedure.
Coordinate with distribution center folks for handling of rejected batches.
Providing details of back order batches to all manufacturing sites on daily basis to keep track of batch release timeline and provide visibility for priority items.
Handling of temperature and humidity monitoring systems, including alerts and excursions, and coordinating with the Vendor for any requests or fixes.
Review weekly reports of temperature and humidity of the warehouse area
Handling of destruction of non-controlled products and controlled substance drug products.
Handling of Quality Inspection of all incoming batches per current approved procedure
Handling of drug product sample management.
Support in Investigations, Deviations, CAPA, Change Control related to QA and warehouse operations
Support regulatory inspections (FDA, DEA, VAWD/NABP, PADOH etc.)
Ensure US Allentown distribution warehouse is in compliance following CGMP-s
Handle/carry out other QA departmental activities/projects as assigned by the supervisor.
Qualifications
Education
BA/BS or equivalent work experience.
Experience
Minimum 3 to 5 years of related experience in the pharmaceutical industry, specifically in QMS and Batch release.
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.
START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3447873&source=3447873-CJB-0)