11 Oct

Manufacturing Specialist Iii Jobs Vacancy in Brammer Bio Cambridge

Position
Manufacturing Specialist Iii
Company
Brammer Bio
Location
Cambridge Maluku
Opening
11 Oct, 2018 30+ days ago

Brammer Bio Cambridge urgently required following position for Manufacturing Specialist Iii. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Manufacturing Specialist Iii Jobs Vacancy in Brammer Bio Cambridge Jobs Details:

Job Description:

Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.


Job Summary:

The MFG Specialist III in this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist III uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.


Key Duties:

  • Support manufacturing at tech transfer with change controls if needed
  • Support manufacturing corrective and preventative actions
  • Support manufacturing internal and external observations
  • Lead manufacturing investigations if needed
  • Support daily huddle meetings if needed
  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
  • Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
  • Participate in client and planning meetings as requested
  • Maintain and Improve Systems:
    • Support and develop consistent manufacturing/quality standards and/or process for Deviations, Change Controls, and CAPAs in new Quality System
    • Performs training with staff for Deviations, Change Controls, and CAPAs as needed
    • Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
    • Supports cross-functional company goals for Site Metrics
    • Builds cross-functional relationships and enhances relationships with team members
    • Works cooperatively with others to meet group and organizational goals


Required Experience:

Position Requirements:

  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
  • Strong planning, organization and multitasking skills
  • Solid understanding of applicable regulatory requirements.
  • Strong Leadership skills

Education and Qualifications:

  • Minimum of 5 -10 years’ experience in pharmaceuticals manufacturing and/or quality.
  • Bachelor’s degree or above required
  • Strong interpersonal and communications skills; written and oral

Physical Demands:

While performing the duties of this job, the employee is required to

  • Gown aseptically and/or sterile gown as needed.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Keyword: Manufacturing Specialist III
From: Brammer Bio


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