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Actalent Manufacturing Specialist in Cambridge, Massachusetts

Great opportunity to get your foot in the door with one of the top Cell Therapy companies in the Cambridge Area! Must have manufacturing and CAPA/Change Control experience!!

If interested, please reach out directly to Lindsee Allienello at lallienello@actalentservices.com or (617)535-3216.

Description:

Position Summary:

The Manufacturing Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, Preactor), quality systems (deviations, change controls, CAPAs) and implementation of continuous improvement initiatives within the Manufacturing department.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Coordinate and ensure successful completion of manufacturing projects

Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.

Represent Manufacturing on cross-functional teams. Collaborate with other departments including QA, QC, Engineering, Validation, Material Management and Project Management.

Assess process manufacturing performance by observation of the floor operations and review of performance data with the objective of implementing process improvement solutions.

Lead investigations and provide troubleshooting for deviation reports.

Assist in generation of training materials and may assist in providing training on technical aspects of the manufacturing process.

Responsible for implementation of corrective actions.

Assist with the execution of validation protocols.

May participate in regulatory inspections.

Participate in tech transfer activities; assess documentation, materials, training, procedures and systems modifications.

Own changes or assist manufacturing change owner for changes impacting the process.

Lead or participate on the assessment or implementation of special initiatives.

May be required to support manufacturing operations during busy times

Skills:

deviation, CAPA, trackwise, cell culture, mammalian cell culture, regulatory documents, compliance, investigations, SOP writing, SOP, Quality assurance, quality control

Top Skills Details:

deviation,CAPA,trackwise,cell culture,mammalian cell culture,regulatory documents,compliance,investigations,SOP writing,SOP

Additional Skills & Qualifications:

Basic Qualifications:

2-5 years of experience in a biopharmaceutical manufacturing environment.

Familiarity with computer systems such as Preactor, GP, EBR and Trackwise.

Must be familiar with biopharmaceutical equipment and systems

Experience with cGMP Practices and regulatory requirements.

Excellent communication skills, written and verbal.

Organizational and planning skills and the ability to cooperate with others in a team environment.

Experience with Microsoft Office.

Preferred Qualifications:

BA/BS in a scientific discipline or equivalent experience preferred.

Basic laboratory skills, including working with mammalian cell culture

Experience working in an ISO 7 cleanroom environment.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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