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Pharmaceutical Manufacturing Specialist

4 months ago


East Windsor, United States Empower Pharmacy Full time

Position Summary:
As a Pharmaceutical Manufacturing Specialist at Empower, you will be at the heart of our mission to produce innovative medications that transform lives. This critical role ensures our manufacturing processes run seamlessly and efficiently. You will be responsible for planning and executing manufacturing tasks, including scheduling operations, managing materials, and ensuring compliance with stringent industry standards. Your expertise will directly contribute to the production of quality medications that empower people to live healthier, happier lives.

In this dynamic position, your analytical skills will be crucial in identifying and addressing gaps in our processes, utilizing manufacturing software and analytics tools to track key performance indicators (KPIs) and enhance overall performance. Collaborating closely with quality and engineering teams, you will play a key role in the implementation of new devices, equipment, and processes, ensuring robust, reliable, and efficient manufacturing operations.

Duties and Responsibilities:

- Assists operations in execution of tasks related to manufacturing that are within the realms of any of the following:

- Scheduling and Planning of operations (Monthly-Weekly-Daily-Hourly breakdown).
- Creation and maintenance of Standard Operating Procedures (SOPs), Standard Work Instructions and forms.
- Product Development.
- Quality Control process implementation.
- United States Pharmacopeia (USP) 797 and/or current Good Manufacturing Procedure (cGMP) compliance.
- Material/chemical management, receipt and inspection for release and entry into software for use.
- Primary/Secondary/Tertiary Qualification of materials and ingredients
- Analyzes gaps using spreadsheets and analytics software.
- Tracks manufacturing performance related to KPIs.
- Investigates deviations and Corrective Actions / Preventative Actions with quality, engineering, and operations.
- Identifies and implements improvement initiatives to improve yield, reliability, and/or process robustness.
- Works closely with quality and engineering teams to help implement new devices, equipment, and processes into manufacturing including scale up, Installation Qualifications, Operational Qualification, Performance Qualification protocol drafting and review and implementation assistance, and training and implementation on ground floor.
- Plans for and adjusts to unforeseen responsibilities as the company requires.
- Aid in the strategy and execution of stability batches including protocols, SOP’s, materials, etc.
- Helps implement lean manufacturing principles (5S, Gemba, etc.).
- Assists with operations as needed in case of unplanned absences.
- Inventory management and ordering of everyday chemicals, materials, and supplies.
- Responsible for waste management and documentation.
- Initiate Non-Conformance Incidents.
- 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 accommodations may be made to enable qualified individuals with disabilities to perform the 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 workday 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. Employee may need to gown into a cleanroom environment therefore must be able to fully gown in aseptic garb. 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. Vision abilities required by this job include close vision.

Knowledge and Skills:

- Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices.
- Ability to operate a forklift preferred.
- Highly level proficiency with Microsoft Office (Excel, Word, PowerPoint).
- Must be able to pass media fill tests bi-annually.
- Must be able to gown into cleanroom (daily if needed).

**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: Ho