Other - Manufacturing Associate - Pioneer Data Systems
Bothell, 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 I to join their expanding team.
Job Title: Manufacturing Associate I/ Pharma Industry
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:
Performs review of documents, records and procedures supporting 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 logs
Periodic review of validated systems
Review validation deliverables for compliance with Seattle Genetics policies and procedures
Requirements:
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
Hard Skills:
cGMP
Time Management/Organizational skills
Ready to hit the ground running
Soft Skills:
Team Player
Independent
Punctuality
Communication
Willingness to learn
Interview Process:
Virtual (Camera On)
Panel Interview 30-min
Position is in North Creek, WA.
What is the minimum education experience required?
Minimum education required is a High School diploma.
Preferred someone science BG
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: 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:
Performs review of documents, records and procedures supporting 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 logs
Periodic review of validated systems
Review validation deliverables for compliance with Seattle Genetics policies and procedures
Requirements:
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
Hard Skills:
cGMP
Time Management/Organizational skills
Ready to hit the ground running
Soft Skills:
Team Player
Independent
Punctuality
Communication
Willingness to learn
Interview Process:
Virtual (Camera On)
Panel Interview 30-min
Position is in North Creek, WA.
What is the minimum education experience required?
Minimum education required is a High School diploma.
Preferred someone science BG
Source : Pioneer Data Systems