Job Description: Part of the New Product Introduction Team at clients Thousand Oaks, Building 20. Building 20 is a clinical and commercial manufacturing facility supporting patients worldwide.
Job Responsibilities: • Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach. • Strong project management skills, with prior project experience preferred. • Timely closure of change control records in relation to procedural guidance and/or disposition timelines • Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions into Building 20 • Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities • Succinctly communicate verbally and in writing to staff and leadership • Presenting records and business processes to a variety of audiences, including auditors and inspectors • Participating/leading Continuous Improvement Transformation activities • Champion safety and compliance at all times
Day to Day Responsibilities: Owning Change Controls to introduce new products to the Building 20 Clinical and Commercial Drug Product Manufacturing facility Initiate continuous improvement projects Ensure on-time delivery of new products being introduced to Building 20 Manufacturing
Top 3 Must Have Skillset: 1. Project Management 2. Team Player 3. Attention Detail/ Quality Centric Mindset organization, meeting minutes proactive willingness to keep self organized
Basic Qualification: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Qualifications: • Masters Degree • Experience with PAS X Werum software for electronic batch records • Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection • Experience leading change controls in Trackwise • Degree in life sciences or engineering • Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory • Demonstrated technical writing skill • Demonstrated ability to work in a team
Possible Extension: Yes Red Flags: No manufacturing experience, No project management experience, No cross-functional communication skills
Interview Process: Phone Screen then move to WebEx or in-person interviews
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: $29.48/hr.
