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Global Quality Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Engineering, Support

Projektbeschreibung

GLOBAL QUALITY SPECIALIST needed for a long term CONTRACT opportunity with Yoh's client located in NEWARK, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Bachelors degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering
- 4+ years of QA experience in a pharma or biotech industry

WHAT YOU'LL BE DOING:

- Maintains a high level of understanding of relevant production processes and quality systems
- PerformstheQA review and approval of thefollowingGMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
- Change Requests
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
- Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Collaborates in data analysis and report creation on quality metrics and key performance indicators
- (USBC) Act as process execution lead/process owner for one or more of the following areas:
- Accountable for Supplier Management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI's.
- Accountable for Quality management of US Distribution Centers.

WHAT YOU NEED TO BRING TO THE TABLE:

- Excellent oral and written communication skills
- Strong ability and motivation to learn.

WHAT'S IN IT FOR YOU?

Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

WHAT ARE YOU WAITING FOR? APPLY NOW!

Recruiter: Stephanie Tulloch

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2 J2WNECLIN

Ref: AZNJP

SFSF: LS

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh