What are the responsibilities and job description for the Manufacturing Associate position at pfizer?
Manufacturing Associate
*Onsite in North Creek, WA
Summary:
Pfizer 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
- Valid Driver's License and a clean driving record are required
- 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/Schedule:
- This is a fully onsite role in North Creek, WA
- First month (training): Monday - Friday; 7:00 AM - 3:00 PM
- After training period: Either Sunday - Thursday or Tuesday - Saturday
Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued, and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
