Manufacturing Associate - Pioneer Data Systems
North Creek, WA 98021
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in North Creek, WA is currently looking for a Manufacturing Associate to join their expanding team.
Job Title: Manufacturing Associate
Duration: 18 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:
Client is searching for a talented Manufacturing Associate in North Creek, WA
The Manufacturing Associate will perform reviews of documents, records and procedures supporting the release of clinical and commercial GMP products and participate in the development of GMP operations, as assigned. They also perform reviews of validation documentation, and 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
Evaluate discrepancies noted during batch record reviews
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 logs
Periodic review of validated systems
Review validation deliverables for compliance with Seattle Genetics policies and procedures
Qualifications:
High school diploma or GED required
A minimum of 0-3+ years of related experience, a background in science is preferred
Knowledge of cGMP and applicable FDA regulation
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
This is a fully onsite role in North Creek, WA
Our client, a world-leading Pharmaceutical Company in North Creek, WA is currently looking for a Manufacturing Associate to join their expanding team.
Job Title: Manufacturing Associate
Duration: 18 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:
Client is searching for a talented Manufacturing Associate in North Creek, WA
The Manufacturing Associate will perform reviews of documents, records and procedures supporting the release of clinical and commercial GMP products and participate in the development of GMP operations, as assigned. They also perform reviews of validation documentation, and 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
Evaluate discrepancies noted during batch record reviews
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 logs
Periodic review of validated systems
Review validation deliverables for compliance with Seattle Genetics policies and procedures
Qualifications:
High school diploma or GED required
A minimum of 0-3+ years of related experience, a background in science is preferred
Knowledge of cGMP and applicable FDA regulation
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
This is a fully onsite role in North Creek, WA
Source : Pioneer Data Systems
