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Quality Assurance Specialist

Location
Hazelwood, Missouri
Job Type
Permanent
Posted
23 Sep 2022

Description:

The Quality Assurance Specialist supports externally manufactured products. Will be responsible for Batch Reviews, CMO Governance, Quality Support and Deputation with a product portfolio that includes pharmaceutical and biopharmaceutical products.

Batch Review

Preparation of CMO documentation for batch review.

Review of batch records, addressing discrepancies and escalating where required to management.

Preparation of disposition and release certification for reviewed batch records.

CMO Governance

Management and oversight of third party supplier activities relating to the manufacture, packaging and testing of product.

Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.

Continuous monitoring of product and performance from CMOs.

Quality Support and Deputation

Monitoring cold-chain transportation, for both qualification and routine

CMO Maintenance

Input into Technical Quality Agreements

Post-launch support for quality activities in various countries

Management of delegated projects

Audits, Drive the audit readiness programs to ensure audit compliance at all times.

Quality/QMS Projects

Skills:

  • quality systems management
  • cGMP
  • ISO13485
  • Quality assurance
  • capa
  • Batch record review
  • change control
  • CMO Management
  • Quality control
  • Gmp
  • Document control
  • Audit
  • Batch record
  • Chemistry
  • Pharmaceutical
  • gdp

Additional Skills & Qualifications:

  • Bachelor's Degree in scientific discipline, preferred +3-5years' experience working as QA Specialist
  • Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
  • Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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Details

  • Job Reference: 719156775-2
  • Date Posted: 23 September 2022
  • Recruiter: Actalent
  • Location: Hazelwood, Missouri
  • Salary: On Application
  • Job Type: Permanent