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Coordinator, Research and Development

3 months ago

Houston, United States Empower Pharmacy Full time

Position Summary:
Step into the role of Research and Development Coordinator at Empower, where you will be pivotal in driving the advancement of healthcare through innovative research and product development. This critical position is integral in maintaining the integrity and progress of our research initiatives, aligning with our values of people, quality, service, and innovation.

In this essential role, you will support the organization and monitoring of product development and stability studies for new pharmaceutical products. Your responsibilities will include maintaining precise product development protocols, stability schedules, and comprehensive reports. Through meticulous documentation and steadfast adherence to data integrity and regulatory compliance, you will ensure the reliability and accuracy of all research outputs thereby upholding our high standards of data integrity and regulatory compliance.

Your day-to-day activities will also involve collecting, analyzing, and interpreting stability data to identify trends and deviations, thus ensuring the reliability of our research outcomes. You will coordinate with third-party analytical testing labs to manage sample submissions and procure quotes, maintaining efficiency and timeliness in all transactions. This role requires a collaborative spirit as you work closely with the Research and Development, Manufacturing, and Quality departments to provide essential stability data and support for both new product development and post-approval changes.

Joining Empower as a Research and Development Coordinator is an opportunity to immerse yourself in a role that challenges and leverages your analytical expertise in a meaningful way. You will have opportunities to contribute to our commitment to innovation and excellence in pharmaceutical research. Here, your work will directly impact our ongoing efforts to provide high-quality, innovative medications that support healthier, happier lives.

Duties and Responsibilities:

- Supports the Research and Development department by coordinating and monitoring the product development and stability studies of new products and associated projects.
- Assists in developing and maintaining product development, stability protocols, schedules, reports, and documentation for all studies.
- Works proactively with other cross-functional groups to execute change controls associated with Manufacturing Standard Operating Procedures (SOP’s), protocols, and reports.
- Assists with ensuring the flow of information and documentation during the tech transfer process.
- Collects, analyzes, and interprets stability data, including trends and deviations.
- Coordinates with 3rd party analytical testing labs for sample submissions, quote procurement, and other related tasks in a timely manner.
- Maintains accurate and comprehensive records for all product development activities, ensuring data integrity and traceability.
- Analyzes and interprets lab testing results within the Research and Development and production life cycle.
- Generates and maintains stability reports, including recommendations for product shelf-life and storage conditions.
- Collaborates between Research and Development, Manufacturing, and Quality departments to provide stability data, and support for new product development and post-approval changes.
- Assists with investigating new and existing product deviations.
- Performs other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the work day and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employees will regularly be exposed to areas in which moving mechanical parts, fumes, toxic chemicals are present. The noise level is the office environment is typically quiet, but the employee may occasionally be exposed to loud noises. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employees may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision.

Knowledge and Skills:

- Working knowledge of 21 CFR Part 210 & 211, USP
,
, and
compliance required.
- Strong understanding of stability testing principl