Overview
Sr. Associate – MQO Corporate Safety, QA Jobs in Indianapolis, IN at Lilly
Darmerica was established in April 2016 with the goal of becoming the foremost distributor of bulk pharmaceutical ingredients in the nation. We foresaw a need in the industry for a dynamic new enterprise, which combined a prime distribution location in Davie, FL, with the many years of industry experience of our team. Leveraging these assets, Darmerica was born, with a pedigree of quality and intensive industry knowledge.
Darmerica is a Florida based FDA Inspected, Current Good Manufacturing Practices compliant (“cGMP”), and State Licensed distributor of Active Pharmaceutical Ingredients (“APIs”), Nutraceuticals, Peptides, and other bulk chemicals for the Pharmaceutical and Compounding Pharmacy Industries. Darmerica is licensed to ship nationwide, and is also an FDA Inspected and state licensed relabeling and repackaging facility. In 2019 Darmerica officially assumed control of the distribution business from Attix.
We are looking for Assistant Quality Director at our Florida location. The duties and responsibilities are as follows:
● Oversee the operations of Quality Unit including product releases of all incoming materials, relabeled/repackaged products for storage and shipping of products.
● Prepare and approve all standard operating procedures prior to implementation.
● Qualify the suppliers according to FDA regulations on bulk APIs.
● Maintain the change control, deviations systems, training program, Investigations and tracking of Corrective and Preventive Actions.
● Conduct internal audits, risk assessments and annual quality reviews and prepare applicable reports, including recalls (if any).
● Oversee the calibration program of equipment and inventory temperature monitoring.
● Ensure that adequate environmental temperature monitoring is in place in cGMP facilities.
● Keep the management informed of any significant risks and non-conformities.
● Host inspections by FDA, Board of Pharmacies and customers.
● Review and maintain completed batch records.
● Train personnel in the quality unit on all aspects of cGMP regulations and standard operating procedures.
● Maintain training records.
● Assist operations with daily activities.
MINIMUM REQUIREMENTS:
Master of Science or related field. Will accept a foreign equivalent as determined by a reliable credentials evaluation service which specializes in evaluating foreign educational credentials.
5 years of experience in:
The pharmaceutical industry including qualifying the API (bulk drug) manufacturers domestically and internationally.
Evaluation of drug products’ quality meeting the US FDA and Board of Pharmacy cGMP requirements.
A leadership role managing a quality team in a pharmaceutical cGMP environment.
Product technical support in the pharmaceutical and compounding pharmacy industry.
U.S. FDA and Board of Pharmacy cGMP regulations in a pharmaceutical cGMP environment.
Handling Corrective Action and Preventive Action (CAPA), Deviations, Change Control and investigations in a pharmaceutical cGMP environment.
Preparing and implementing standard operating procedures.
Training quality personnel and managing a quality team’s activities.
Implementing and monitoring of temperature mapping in a cGMP pharmaceutical environment.
Monitoring calibration and validation of equipment in a pharmaceutical cGMP environment.
Board of Pharmacy licensing regulations.
● Must have hosted minimum of one FDA and/or Pharmaceutical Inspection Co-operation Scheme Regulatory Agencies (PIC/S) and Board of Pharmacies cGMP inspections.
● Must have responded to minimum of one FDA 483 and/or any PIC/S inspection reports.
● Must have handled minimum of one recall of potentially affected products in a pharmaceutical cGMP environment.
●Must be familiar with 21 CFR Part 210 and have handled APIs (bulk drugs).
Salary Range: $80,000-$90,000, plus up to 10% of salary performance based bonus, prorated quarterly payout after completing probation.
Benefits: Employee Benefit Plan (after 6 months)
Location: Ft. Lauderdale (Davie), Florida
**All new hires are subject to a Background Check/Screening**
CONTACT: Please direct all questions and applications in response to this ad to Kyle Hamza at [email protected].
Job Type: Full-time
Pay: $80,000.00 – $90,000.00 per year
Benefits:
Paid time off
Schedule:
8 hour shift
Work Location: In person
Title: Sr. Associate – MQO Corporate Safety, QA
Company: Lilly
Location: Indianapolis, IN
