Quality Assurance Manager, DEA
Company Name:
Kremers Urban
KREMERS URBAN PHARMACEUTIALS is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent
services
to our customers and creating significant value for our investors.
job
Summary:
This
manager
will assist the Director, QA DEA Activities in the implementation and monitoring of DEA related activities throughout the Kremers Urban (KU) facility. This manager will assist with the training and numerous activities necessary to ensure KU's compliance pursuant to 21 CFR 1300. This manager will be considered a subject matter expert for DEA activities and available to answer questions pursuant to DEA regulations. This manager will assist with DEA inspections and ensure DEA related questions are answered appropriately internally and externally.
Essential Functions:
Identify deficiencies and institute corrective actions relative to controlled substance handling throughout facility.
Regular review of documents used to manage and track all controlled substance materials.
Ensure accurate accountability of all controlled substance materials received, manufactured, analyzed, shipped, and destroyed via regular accountability audits and reviews,
Security reviews to ensure compliance with 21 CFR 1301, including periodic access list reviews.
Oversight for suspicious order monitoring requirements, due diligence activities, and ARCOS reporting.
Work with all departments relative to DEA Form 222 (order forms), DEA Form 106 (theft and loss), DEA Form 41(destruction), and reverse distributor activities.
Regular review of controlled substance access lists throughout the KU facility.
Assist in training KU staff on relevant DEA regulations.
Assist during DEA Audits and security reviews.
Routine review of Power of Attorney files.
Prepare or assist in the preparation of SOPs
Work with departments in gathering information, and submitting documents to obtain quota requests for controlled substances.
Registration renewal oversight.
Experience:
At least 2 years previous work experience in DEA regulatory compliance.
Strong written and oral communication skills.
Strong interpersonal skills and ability to work in a team setting.
Familiarity with MS Excel, MS Access and Power Point.
Strong organization and implementation skills.
Education:
BS or BA Degree preferred
Work history and training in DEA Regulatory Compliance
Supervises/Manages:
This
position
may have supervisory responsibility.
About Our Company:
We foster an
employee
culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KREMERS URBAN. All of our openings include the high quality benefits you would expect from an international pharmaceutical leader.
KREMERS URBAN is an equal opportunity employer, committed to a drug free workplace.
Date: 2014-03-13
Country: US
State: IN
City: Seymour
Postal Code: 47274
Category: Quality Assurance - Quality Control
Job Type: Full TimeEstimated Salary: $20 to $28 per hour based on qualifications.
Kremers Urban
KREMERS URBAN PHARMACEUTIALS is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent
services
to our customers and creating significant value for our investors.
job
Summary:
This
manager
will assist the Director, QA DEA Activities in the implementation and monitoring of DEA related activities throughout the Kremers Urban (KU) facility. This manager will assist with the training and numerous activities necessary to ensure KU's compliance pursuant to 21 CFR 1300. This manager will be considered a subject matter expert for DEA activities and available to answer questions pursuant to DEA regulations. This manager will assist with DEA inspections and ensure DEA related questions are answered appropriately internally and externally.
Essential Functions:
Identify deficiencies and institute corrective actions relative to controlled substance handling throughout facility.
Regular review of documents used to manage and track all controlled substance materials.
Ensure accurate accountability of all controlled substance materials received, manufactured, analyzed, shipped, and destroyed via regular accountability audits and reviews,
Security reviews to ensure compliance with 21 CFR 1301, including periodic access list reviews.
Oversight for suspicious order monitoring requirements, due diligence activities, and ARCOS reporting.
Work with all departments relative to DEA Form 222 (order forms), DEA Form 106 (theft and loss), DEA Form 41(destruction), and reverse distributor activities.
Regular review of controlled substance access lists throughout the KU facility.
Assist in training KU staff on relevant DEA regulations.
Assist during DEA Audits and security reviews.
Routine review of Power of Attorney files.
Prepare or assist in the preparation of SOPs
Work with departments in gathering information, and submitting documents to obtain quota requests for controlled substances.
Registration renewal oversight.
Experience:
At least 2 years previous work experience in DEA regulatory compliance.
Strong written and oral communication skills.
Strong interpersonal skills and ability to work in a team setting.
Familiarity with MS Excel, MS Access and Power Point.
Strong organization and implementation skills.
Education:
BS or BA Degree preferred
Work history and training in DEA Regulatory Compliance
Supervises/Manages:
This
position
may have supervisory responsibility.
About Our Company:
We foster an
employee
culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KREMERS URBAN. All of our openings include the high quality benefits you would expect from an international pharmaceutical leader.
KREMERS URBAN is an equal opportunity employer, committed to a drug free workplace.
Date: 2014-03-13
Country: US
State: IN
City: Seymour
Postal Code: 47274
Category: Quality Assurance - Quality Control
Job Type: Full TimeEstimated Salary: $20 to $28 per hour based on qualifications.
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