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Batch Record Reviewer

3 months ago

Houston, United States Empower Pharmacy Full time

Position Summary:
At Empower, the Batch Record Reviewer plays a pivotal role in ensuring our products maintain the highest standards of quality, aligning with our vision of expanding access to quality, affordable medication.

In this dynamic role, you will be at the heart of our production processes, meticulously reviewing post-execution batch records across our various manufacturing streams, including Sterile and Solid Dose Manufacturing. Your keen eye for detail will ensure that all documentation aligns with cGMP standards, directly contributing to the quality of our products. Working closely with both Manufacturing and Quality personnel, you will facilitate seamless documentation corrections and maintain vital metrics that drive our commitment to excellence.

Your contributions will be essential in presenting key metrics and ensuring that all errors and corrections are resolved efficiently and in accordance with our SOP requirements. Your proactive approach to problem-solving and your dedication to quality will make you an integral part of our team.

If you are proactive, detail-oriented, passionate about making a difference and excited about the opportunity to work in a vibrant, forward-thinking environment, we invite you to join us at Empower. Together, we can create a healthier future and transform the pharmaceutical industry for the better.

Duties and Responsibilities:

- Completes post execution review of all Production batch records, including Sterile Manufacturing, Solid Dose Manufacturing, and Inspection and Labeling.
- Owns the Batch Record flow for in-process Production documentation.
- Coordinates intradepartmental documentation corrections with applicable Manufacturing personnel.
- Works closely with Quality personnel to incorporate clarifying information on cGMP documentation, as needed.
- Creates and maintains tools to track and communicate metrics surrounding the documentation performance by the team.
- Assists with the storage and organization of completed documentation for seamless retrieval.
- Presents monthly metrics surrounding Operations GDP performance.
- Assists in creation of red lined documents by providing error rate data to Manufacturing Specialists and departmental leadership.
- Performs the submission of non-conformances related to documentation errors found during the review process, as applicable.
- Assures all errors and corrections are resolved according to SOP requirements.
- Ensures adequate quantities of administrative supplies to support batch record completion activities.
- 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 stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is required to stand for most of the duration of the shift (5 days/8 hours) and to move about the office and around the corporate campus. The employee must stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Vision abilities required by this job include close vision, also the ability to lift 50 lbs. objects from the floor is required. The employee must be able to wear proper PPE, including but not limited to scrubs, hair net, beard cover, shoe cover, gloves, N-95 mask, safety glasses, lab gown, full body coverall, full-face and/or half-face respirators while performing their daily tasks in Non-Sterile Hazardous and Non-Hazardous Lab controlled environments.

Knowledge and Skills:

- Meticulous and self-motivated.
- Skills in Microsoft Word and Excel are required.
- Ability to collaborate effectively with a team to achieve goals around safety, quality, and delivery.
- Ability to carry out and/or deliver detailed written and oral instructions.
- Must be able to perform fundamental mathematical calculations.

**Key Competencies**
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems.
- Ensures Accountability: Holds self and others accountable to meet commitmen