QUALITY ASSURANCE SPECIALIST

$40-$50 an hour

6-12 months

Hazelwood MO

The Quality Assurance Specialist supports integration of newly acquired products into the existing Mallinckrodt quality system. The role supports externally manufactured products within the Specialty Brands team. The Global External Supply function manages all externally manufactured products, including a product portfolio consisting of pharmaceutical, biopharmaceutical and medical device products.

Essential Functions

• Batch Review

o Documentation for CMO batch review.

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

o Preparation of disposition and release certification for reviewed batch records.

• CMO Governance

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

o Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product. Same for contract laboratories in relation to test data for release and stability.

o Continuous monitoring of product and performance from CMOs.

• Quality Support and Deputation

o Monitoring cold-chain transportation, for both qualification and routine

o CMO Maintenance

o Input into Technical Quality Agreements

o Support for product complaints

o Support for delegated projects

• Stablility Program

o Protocol review

o Data review and management

• Audits

o Drive the audit readiness program to ensure audit compliance at all times.

• Quality/QMS Projects

o As required.

Education / Experience / Skills:

• Bachelor’s Degree in scientific discipline, preferred +5-7years’ experience working as QA Specialist

• Direct experience working with Quality Systems (deviations, change controls, complaints, training, supplier qualification and document management systems)

• Knowledge of cGMP requirements for sterile pharmaceutical manufacturing and knowledge of GDP and ISO 13485