THIS ROLE WILL REQUIRE MARYLAND RELOCATION
This is a Permanent Full-Time Position
Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions). This company has the experience, expertise, and a successful track record in completing the development of life-changing pharmaceuticals and medical devices. Together with their clients, they work to bring about the treatment of many forms of cancers, diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
The Specialist for Metrology and Lyophilization Operations is responsible for the execution of the metrology and lyophilization administrative functions required to support the facility and process equipment at the fill/finish facility.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Designs, develops, implements, and maintains calibration and lyophilization processes and procedures for new and existing equipment and instrumentation.
- Coordinates calibration of instrumentation necessary for maintaining production equipment, laboratory equipment, and other auxiliary measurement systems.
- Maintains detailed calibration and lyophilization records.
- Coordinates outside calibration activities with vendors.
- Applies engineering principles to generate solutions to problems.
- Established procedures with some supervision.
- Possess and apply a broad knowledge of principles, practices, and procedures of a particular field of specialization to the completion of difficult assignments.
- Identify, and pursue, potential continued improvement activities.
- Work well with others, build, and maintain positive employee relations.
- Will assist others in the Engineering and Facilities department as needed.
- Demonstrated ability to perform routine work without instruction; requires general instructions on non-routine assignments.
- Deviations: Independently initiates and leads investigations of a wide variety of difficult and complex problems to determine root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events with the same root cause.
- CAPA System: Utilize this Quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
- Change Control System: Identify and initiate changes through collaborative efforts with Quality Assurance and applicable departments in response to deviations, CAPA’s and departmental continuous improvement projects.
- Utilizes multifunctional teams to implement process and continuous improvements within Quality Systems (Deviation, CAPA, CC, SOPs, etc.)
- Quality Metrics: Provide management with pertinent information regarding the state of all Metrology and Lyophilization Operations quality systems and continuous improvement projects.
- Internal Audits: Respond to internal audit findings, including root cause analysis, identification of corrective and/or preventive actions (both global and specific).
- Purchase Orders: Create purchase requests in support of Quality Systems and Continuous Improvement Projects.
- Schedule and coordinate vendor calibrations.
- Serves as an SAP Master Data coordinator.
- Responsible for tracking work order review and approval process.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Education and Skills
- Bachelor's degree or equivalent level of skill and experience, preferably in an applied science.
- Experience with electronic document management, learning management, deviation, CAPA, and change control systems.
- 3-5 years in an FDA regulated industry.
- Expert understanding of regulations governing supported processes and systems.
- Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
- Ability to work independently and in a team setting with minimal supervision.
- Ability to make sound decisions regarding quality and compliance related issues with minimal supervision
- Prior experience with SAP
- Strong project management skills
- Strong background in cGMP principles and concepts
- Proficiency in Microsoft Word and Excel
- Excellent organization and communication skills
- Should have experience/knowledge of Reliability / Predictive maintenance and Statistical Process Control
- Must have the ability to multi-task and coordinate workload by priority
- Must be customer-oriented and quality-driven
Work Environment Requirements
- Work around extreme temperatures – cold or hot
- Work around noise above conversation level
- Work in restricted access to laboratory area
- Exposure to dust/gas/fumes/steam/chemicals
- Work with Select Agents as defined by the CDC
- Work irregular hours that often include nights and weekends
- Work in multiple locations
Job Type: Full-time
Pay: From $1.00 per year
- Dental insurance
- Health insurance
- Paid time off
- Parental leave
- Relocation assistance
- Vision insurance
- 8 hour shift
- Bonus pay
- Signing bonus
- Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
- Are you willing to relocate to Maryland?
- Pharmaceutical: 5 years (Preferred)
- Metrology: 5 years (Preferred)
- One location