Disposition Senior Specialist II - Alewife

11 - 15 years experience  • 

Salary depends on experience
Posted on 03/20/18
Cambridge, MA
11 - 15 years experience
Salary depends on experience
Posted on 03/20/18

Primary Duties

  The role is accountable for disposition activities with the QA Disposition group supporting the Alewife Site.

The scope of operations includes unpurified bulk (UPB) and drug substance (DS) disposition activities performed in support of manufacturing activities executed at the Alewife Site within the Biologics Operating Unit.

This position will be responsible for the timely disposition of UPB and DS in line with global regulatory expectations and Shire standards.

This position will be responsible for working with cross functional groups in each department supporting manufacturing operations within the Alewife Site organization. This position is responsible for ensuring consistency and communication, where appropriate, across the manufacturing operating sites.

This individual will partner closely with other QA groups, QC, Manufacturing, Compliance, Materials Management, Regulatory and Supply Chain to ensure timely disposition of intermediates and products.

Strong collaboration and the ability to effectively work with cross functional groups are critical to success.

Responsibilities

60%                Disposition Activities

10%               Quality System Activities

15%               Site Metrics

5%                 InspectionSupport Activities

Direct responsibilities include:
Disposition Activities (60%)
• Responsible for review of all criteria required for disposition of raw materials and products
• Responsible for review of investigations and quality systems related to disposition of specific batches
• Responsible for SAP transactions relevant to disposition
• Responsible for collaborating with key stakeholders including but not limited to Supply Planning, Materials Management and Supplier Quality relative to raw material quality concerns and batch disposition planning
• Accountable for meeting functional area goals and objectives as they relate to disposition activities

Quality System Activities (10%)
• Responsible for preparing post release notifications and quality alerts as required
• Responsible for preparing quality disposition memos as required
• Responsible for reviewing Material Review Board presentations
• Responsible for representing quality on complex investigations and multi-disciplinary teams as required

• Responsible for support of batch disposition production data for Annual Product Quality Review

Site Metrics (15%)
• Responsible for metrics around disposition
• Group metrics’ tracking and compliance
• Responsible for presenting disposition metrics in various forums (i.e. QMR)

Continuous Improvement Activities (10%)
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs in a compliant manner.

InspectionSupport Activities (5%)
• Support regulatory submissions and inspections

Education and Experience Requirements

• BS with 10+ years relevant Quality experience
• Quality experience must include disposition processes and complex decision making
• Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.
• A minimum of 5 years in a cGMP biotech and/or pharmaceutical environment plus a minimum of 3 years specific to disposition of UPB and DS.
• Significant experience in review of quality system and disposition requirements
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Strong business acumen (Operations, productivity, continuous improvements)
• Experience interfacing with regulatory bodies
• High level of professional competence.

Key Skills, Abilities, and Competencies

• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Strong business acumen (Operations, productivity, continuous improvements)
• Experience interfacing with regulatory bodies
• High level of professional competence.

Complexity and Problem Solving

• Significant experience in review and evaluation of quality system and disposition requirements

• Quality experience must include disposition processes and complex decision making
• Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.

Internal and External Contacts

This individual will partner closely with other QA groups, QC, Manufacturing, Compliance, Materials Management, Regulatory and Supply Chain to ensure timely disposition of raw materials and products.

Other Job Requirements

 Local travel between sites within Lex Site including satellite locations as required

Req ID: R0019904

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