Shift Quality Assurance (33125)
Job Details
Full Job Description
Job Description
Overview:
The Plant Quality
Assurance (PQA) Snr Associate will report to the QA Manager and will
be a core member of the site Quality Assurance team. The PQA Snr
Associate will serve as Quality point of contact for manufacturing
operations.
The site is focused on
continuous improvement of all work processes and practices, therefore
in addition to routine Quality Assurance duties, PQA Snr Associates
may be asked to carry out additional work functions to support site
continuous improvement activities.
Preferred Qualifications & Experience:
• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams
and proven abilities in decision making.
• Strong
organizational skills, including ability to follow assignments through
to completion.
• Demonstrated ability in problem solving
and experience in managing Root Cause Analysis / Non Conformance
/Deviation investigations.
• Experience working in
aseptic operations, protein formulation, vial and syringe filling.
• Knowledge of applicable Regulatory requirements, and
ability to evaluate compliance issues.
Key Responsibilities:
o Perform all activities
in compliance with safety standards and SOPs.
o Write,
review and approve Standard Operating Procedures in accordance with
Policies.
o Provide Quality support for triage and
investigation of all classes of non-conformance (NC) events.
o Review and approval of deviations for closure ensuring
compliance with appropriate documentation.
o
Participates in customer complaint investigations.
o
Provides training and advice to staff in order for them to perform
their desired functions.
o Observe and provide real-time
quality oversight, and support for production unit operations,
extending to formulation, vial and Syringe Fill Finish related
activities, including observation and provision of direction during
media fills and assessment of aseptic interventions.
o
Review/approve production batch records, and associated documentation
in preparation for Qualified Person disposition activities.
o Review and approve cGMP records ensuring compliance with
appropriate documentation.
o Support continuous
improvement and Operational Excellence initiatives.
o
Any other tasks/projects assigned as per manager’s request.
Basic Qualifications & Experience:
o University degree. Engineering or Science related
discipline preferred.
o Relevant experience (4 yrs +)
working in the pharmaceutical or biotechnology industry or other
combination of experience and educational background that may
otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
o
Excellent written and verbal communication skills.
o
Experience working with dynamic cross-functional teams and proven
abilities in decision making.
o Strong organizational
skills, including ability to follow assignments through to completion.
o Demonstrated ability in problem solving and experience
in managing Root Cause Analysis /Deviation investigations.
o Experience working in aseptic operations, protein
formulation, vial and syringe filling.
o Knowledge of
applicable Regulatory requirements, and ability to evaluate compliance
issues.
Shift Quality Assurance (33125)
Adaptive HVM
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