Duties: DistributionThis role supports the Quality Disposition and Distribution of clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good Distribution Practices. This includes performing Batch Record Review, disposition of LDP and FDP, supporting cold chain distribution, providing quality oversight to technical transfer activities related to labeling and packaging operations, and process improvements at CMO’s (Contract Manufacturing Organization). This position interacts cross-functionally with all areas of Quality, Supply Chain, Clinical Operations, and Regulatory Affairs.
Primary Responsibilities: •Performs Batch Record Review and Release of LDP and FDP at the CMO. •Provides quality documents to Regulatory Affairs and Clinical Operations to support Single-Patient-Use (SPU) distribution. •Partners with the Qualified Person on Batch Record Review and Release of LDP and FDP. •Support technical transfer activities and ensure compliance of labeling, packaging, and distribution operations at CMO. •Support quality aspects related to cold chain distribution. •Serves as quality contact and support major nonconformance investigations, CAPA implementation and change control, document revision, and product complaints related activities. •Provides routine Quality Assurance & Compliance support, and assess the upcoming regulations impacting the compliance activities of labeling, packaging, and distribution activities •Drafts and approves related controlled documents such as SOPs, Work Instructions, and Forms •Optimizes the batch packaging and distribution process and workflow, drives continuous improvements in the areas of labeling, packaging, and distribution •Support New Product Introduction (NPI), evaluates and assures that the new or revised process that includes the product labeling, packaging & distribution are compliant with the current regulations & meeting the product specifications •Supports IND, CTA preparation, and Audit readiness initiatives
Education Qualifications: •Bachelor’s Degree in Engineering or Life Sciences. •5+ years of related Pharmaceutical or Biotech industry experience in GMP regulated Biologics or Pharmaceutical environment •Experience in a commercial phase pharmaceutical environment •Experience with Contract Manufacturing Organizations (CMOs) •Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues •Root Cause Analysis •Ability to effectively plan, organize work activities and prioritize task completion to meet deadlines •Strong knowledge in 21 CFR 210/211, 21 CFR 1271, and 10 CFR 810, Eudralex volume 4, and ATMPs preferred •Flexibility in working schedule (may occasionally require off hours and weekend work) •Demonstrate ability to work in a team environment to develop, implement and deliver on goals •Demonstrate ability to work successfully and with an appropriate sense of urgency in a nimble fast paced matrixed environment •Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills •Strong problem solving and analytical skills with demonstrated ability to be detail-oriented; while managing multiple projects simultaneously •Strong team player and ability to collaborate cross-functionally •Role model for TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
CPRA: The Company 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.
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: $44.00/hr.
