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12493
Contract

Sr. Quality Specialist

Location: Boston MA, Massachusetts

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Senior Quality Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Contract – 6 months+
  • Pay rate:  $80-90/hr.
  • Job Location:  Boston, MA
  • Job#: bh12493

Senior Quality Engineer

  • MS with 2-3 years of relevant work experience, or BA in a scientific or allied health field with minimum 5 years of relevant work experience
  • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role
  • Focus on materials management, raw material release and project management experience will be helpful
  • Pharma background preferred

The Temporary Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Temporary Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Sr. QA Manager

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES

 

Key Leadership Skills

  • Cross- functional collaborator
  • Results Driver

Key Knowledge/ Skills and Competencies

  • Ability to perform functions independently in accordance with cGMP guidelines.
  • Strong written and oral communication skills required
  • Good interpersonal skills required
  • Ability to work effectively and meet challenging timelines in a fast –paced and high throughput environment
  • Strong organizational skills, work ethics and respect for all customers.
    • Ability to independently coordinate with cross-functional teams
    • Ability to think strategically and tactically, balancing these as workload changes.
  • Attention to detail
    • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
    • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role
    • Experience with release of incoming materials and materials management
    • Project management skills desirable
    • Medical device experience a plus

KEY RESPONSIBILITIES:

As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management

 

Product Release – Internal Manufacturing

 

  • Responsible for reviewing batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
  • Responsible for archival of batch records and other supporting documents in QDoCCs

 

Compliance Oversight of Internal Operations and Quality Systems

  • Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
  • Review and approval of Manufacturing documents (as required)
  • Responsible for raw material release, area clearance, line clearance and equipment release
  • Provide QA support of change controls, GMP investigations and CAPAs (as required). Responsible for updating QA database to support generating performance metrics, trends.
  • Participate in compliance walkthroughs and help drive the closure of any observations
  • Responsible for identifying risks and communicating gaps for GMP process/systems
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in inspection readiness and support activities (as necessary)
  • Participate in process improvement initiatives (as necessary).
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner

 

REQUIRED EDUCATION AND EXPERIENCE:

  • Demonstrated success by independently coordinating with cross-functional teams
  • Experience providing QA support and oversight of Material Management operations including incoming material release.
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
    • cGMP’s and associated CMC regulatory considerations
    • experience with continuous manufacturing a plus
  • Experience with network-based applications such as Oracle, TrackWise, VeeQMS
  • Experience providing QA support and oversight of GMP manufacturing operation including batch release

Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!