Quality Assurance Manager
ISK Animal Health LLC.
ISK Animal Health LLC.
Concord Township, OH Concord Township, OH Full-time Full-time $108,000 - $144,000 a year $108,000 - $144,000 a year Scope The position of Manager, Quality & Regulatory Affairs, will be responsible for all Quality Assurance (QA) oversight activities with contractors manufacturing, testing, packaging, distributing and/or holding for those products which he/she is responsible, providing guidance to ensure compliance with Company, regulatory authority requirements and current Good Manufacturing Practice (cGMP).
An individual with aseptic manufacturing experience is highly desired.
In addition, this role requires experience with the FDA.
This position will liaise with internal functions such as Supply Chain and Business Development & Sales as well as with external consultants for Regulatory Affairs, Manufacturing, and Quality not only for daily operations with contractors, but also in support of projects for new or existing products and/or promotional activities.
Job Duties:
1.
Engage in various QA responsibilities with contractors, such as in the review and approval of master and executed batch records, validation protocols and final reports for process and analytical activities, investigation reports, stability commitments, Manufacturing Changes and Stability Report (MCSR), Annual Product Review (APR) and Chemistry, Manufacturing and Control document (CMC) submissions, etc.
2.
Oversee contract manufacturers, providing guidance from a QA perspective, to ensure compliance with company and regulatory authority requirements/cGMP for such activities as change management, cleaning/process/equipment/method validations, process optimization, scale-up and registration batch manufacture, effectiveness of corrective and preventive actions (CAPA) for investigations, deviations, and complaint handling.
3.
Evaluate trends periodically for key process indicators, such as customer complaints, deviations, out of specification (OOS) investigations, stability, CAPA, etc.
to ensure systems are functioning in compliance with Company and regulatory authority requirements/cGMP; implement appropriate actions where necessary.
4.
Manage information flow with contractors for product defect complaint investigations, ensuring complaints are thoroughly investigated and reported appropriately and timely as required by the type of investigation, Company procedures and regulatory authority requirements/ cGMP.
5.
Maintain and/or establish Quality Agreements with contractors to ensure adherence to Company and regulatory authority requirements/cGMP.
6.
Evaluate new or existing contractors, assessing compliance with company and regulatory authority requirements, to support development, testing, commercial manufacture, packaging and/or storage of new or existing products.
7.
Support projects from a QA perspective for new or existing products and/or promotional activities.
8.
Interact with external consultants for Regulatory Affairs to ensure that ISK Animal Health remains in compliance with all applicable laws and regulations.
9.
Participate in seminars and other training courses to obtain proficiency in animal health Regulatory Affairs.
10.
Oversee pharmacovigilance activities and ensure all necessary reports are filed with the appropriate authorities.
11.
Coordinate with Supply Chain as necessary to ensure sufficient product available with the necessary remaining shelf life.
12.
Other duties as required by the VP of Operations.
Job Type:
Full-time Pay:
$108,000.
00 - $144,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid parental leave Paid time off Parental leave Relocation assistance Tuition reimbursement Vision insurance Experience level:
7 years Schedule:
8 hour shift Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
ISK Animal Health LLC.
Concord Township, OH Concord Township, OH Full-time Full-time $108,000 - $144,000 a year $108,000 - $144,000 a year Scope The position of Manager, Quality & Regulatory Affairs, will be responsible for all Quality Assurance (QA) oversight activities with contractors manufacturing, testing, packaging, distributing and/or holding for those products which he/she is responsible, providing guidance to ensure compliance with Company, regulatory authority requirements and current Good Manufacturing Practice (cGMP).
An individual with aseptic manufacturing experience is highly desired.
In addition, this role requires experience with the FDA.
This position will liaise with internal functions such as Supply Chain and Business Development & Sales as well as with external consultants for Regulatory Affairs, Manufacturing, and Quality not only for daily operations with contractors, but also in support of projects for new or existing products and/or promotional activities.
Job Duties:
1.
Engage in various QA responsibilities with contractors, such as in the review and approval of master and executed batch records, validation protocols and final reports for process and analytical activities, investigation reports, stability commitments, Manufacturing Changes and Stability Report (MCSR), Annual Product Review (APR) and Chemistry, Manufacturing and Control document (CMC) submissions, etc.
2.
Oversee contract manufacturers, providing guidance from a QA perspective, to ensure compliance with company and regulatory authority requirements/cGMP for such activities as change management, cleaning/process/equipment/method validations, process optimization, scale-up and registration batch manufacture, effectiveness of corrective and preventive actions (CAPA) for investigations, deviations, and complaint handling.
3.
Evaluate trends periodically for key process indicators, such as customer complaints, deviations, out of specification (OOS) investigations, stability, CAPA, etc.
to ensure systems are functioning in compliance with Company and regulatory authority requirements/cGMP; implement appropriate actions where necessary.
4.
Manage information flow with contractors for product defect complaint investigations, ensuring complaints are thoroughly investigated and reported appropriately and timely as required by the type of investigation, Company procedures and regulatory authority requirements/ cGMP.
5.
Maintain and/or establish Quality Agreements with contractors to ensure adherence to Company and regulatory authority requirements/cGMP.
6.
Evaluate new or existing contractors, assessing compliance with company and regulatory authority requirements, to support development, testing, commercial manufacture, packaging and/or storage of new or existing products.
7.
Support projects from a QA perspective for new or existing products and/or promotional activities.
8.
Interact with external consultants for Regulatory Affairs to ensure that ISK Animal Health remains in compliance with all applicable laws and regulations.
9.
Participate in seminars and other training courses to obtain proficiency in animal health Regulatory Affairs.
10.
Oversee pharmacovigilance activities and ensure all necessary reports are filed with the appropriate authorities.
11.
Coordinate with Supply Chain as necessary to ensure sufficient product available with the necessary remaining shelf life.
12.
Other duties as required by the VP of Operations.
Job Type:
Full-time Pay:
$108,000.
00 - $144,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid parental leave Paid time off Parental leave Relocation assistance Tuition reimbursement Vision insurance Experience level:
7 years Schedule:
8 hour shift Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
