What are the responsibilities and job description for the Manufacturing Associate position at Pioneer Data Systems?
Position Details :
Our client, a world-leading Pharmaceutical Company in North Creek, WA is currently looking for a Manufacturing Associate I to join their expanding team.
Job Title : Manufacturing Associate I / Pharma Industry
Duration : 17 months contract, extendable up to 36 months
Location : North Creek, WA
Note :
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description :
Manufacturing Associate
Onsite in North Creek, WA
Summary :
Client is searching for a talented Manufacturing Associate to join their team in North Creek, WA!
The Manufacturing Associate performs review of documents, records and procedures supporting the release of clinical and commercial GMP products and participates in development of GMP operations, as assigned.
Performs review of validation documentation, periodic reviews of validated systems, and / or procedures, as assigned.
Responsibilities :
Compile and perform lot file review including assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically
Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations
Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews d. GMP incident / deviation review
Apply the principles of good quality systems and GMP, as assigned on a daily basis
Create and revise standard operating procedures (SOP's) as needed
Assist with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring
Assign part and lot numbers and maintain log
Periodic review of validated system
Review validation deliverables for compliance with Seattle Genetics policies and procedures
Qualifications :
High school diploma or GED required; science background preferred
A minimum of 0-3 years of experience in a related field required
Knowledge of cGMP and applicable FDA regulations
Detail-oriented team player
Able to independently review documentation and identify gaps
Experience reviewing GMP documentation including protocols, reports, batch records and data
Ability to maintain logs, schedules
Ability to organize lot documentation, validation plans, protocols, data, and reports in controlled document system
Must be able to organize information in a consistent and retrievable manner
Ability to work effectively in a fast-paced environment
Location :
This is a fully onsite role in North Creek, WA
