Title: Manufacturing Associate l Duration: 18 Months Location: Bothell, WA
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 1. Compile and perform lot file review including assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically: a. Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations b. Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews . GMP incident/deviation review 2. Apply the principles of good quality systems and GMP, as assigned on a daily basis 3. Create and revise standard operating procedures (SOP’s) as needed 4. Assist with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring 5. Assign part and lot numbers and maintain logs 6. Periodic review of validated systems 7. 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: 1. cGMP 2. Time Management/Organizational skills 3. Ready to hit the ground running
Soft Skills: 1. Team Player 2. Independent 3. Punctuality 4. Communication 5. Willingness to learn
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.
