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Sr. Quality Specialist, QA Engineering - 17213

Boston, MA

Posted: 11/21/2022 Industry: Engineering and Technical Job Number: 15078

Job Description

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: Sr. Quality Specialist

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: 6+ months contract, possible extension
  • Pay rate: $75 - $80/hr
  • Job Location: Boston, MA (100% onsite)
  • Job#: bh15078-17213

 

Sr. Quality Specialist
 

In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.

 

OVERVIEW

The Sr. Quality Specialist – QA Engineering is knowledgeable in the principles and application of quality assurance and compliance. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The Sr. Quality Specialist supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

 

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES

Key Knowledge/ Skills and Competencies:

  • Ability to thrive in a high throughput environment
  • Collaboration / Teamwork / Conflict Management
  • Ability to independently support cross-functional teams and represent the Quality unit
  • Communication/ Influencing
  • Ability to effectively influence others within technical area of expertise
  • Ability to evaluate quality matters and make suggestions utilizing risk-based approach
  • Flexibility/Adaptability
  • Attention to detail

 

Knowledge in the following areas:

  • Global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • Knowledge of ASTM E2500, CSV/GAMP, and other associated standards
  • Demonstrated ability to work independently to provide QA support for large, multifaceted projects

 

KEY RESPONSIBILITIES               

Primarily responsible with providing quality oversight and support to VMC operations in the following key areas/activities; engineering, validation/qualification, facilities and utilities support.

 

Compliance Oversight of Internal Operations – QA Engineering:

  • Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
  • Review and approval of qualification activities, and periodic assessments.
  • Review and approval of trending programs (equipment, facility, utilities, etc.)
  • Support EM and UM programs and control programs (Veriteq, pest control)
  • Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned. 

 

Compliance Oversight of Quality Systems:

  • Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks.  Support collaboration with customers to ensure quality systems are monitored and established metrics are met.
  • Responsible for monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
  • Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.
  • Responsible for identifying risks and communicating gaps for GMP process/systems.

 

Audit / Inspection Support:

  • Participate in inspection readiness activities and provide support during regulatory site inspections.  Provide post inspection support to address any regulatory observations.
  • Individual Development and Training
  • Responsible for timely completion of trainings (100%)

 

REQUIRED EDUCATION AND EXPERIENCE:

Demonstrated success independently leading cross-functional teams

Experience providing QA support and oversight of GMP manufacturing operation

 

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 equipment, facilities and utility system qualifications activities in a cGMP setting, including change controls
  • Experience with event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with Veeva and Nuvolo preferred.
  • B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience

 

 

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!

Meet Your Recruiter

Caroline Driscoll
Major Account Mgr, Sr. Technical Recruiter

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