Sr QA Specialist

Job Title: Sr QA Specialist - I

Duration: 12 Months

Location: El Segundo, CA

NOTE: Position is Day Shift including weekends and requires onsite presence.

Seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is located at our El Segundo, CA site and report into the Associate Director of Quality Operations.

Responsibilities

• Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
• Review batch-related documentation and ensure resolution of issues to release product
• Review batch-related shipment documentation to ensure product shipment remained in control
• Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
• Provide QA oversight and (limited) approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
• Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved.
• Support and participate in investigations, including batch record review.
• Ensure process control measures are in place and followed in product manufacturing
• Maintain metrics related to product disposition in support of the Management Review
• Generate and update procedures, forms and other documents
• As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions, etc.
• Generate and report data for management
• Maintain production (finite), disposition, and team schedules
• Represent Disposition or QA Ops at plant and multi-site scheduling meetings
• Provide QA representation on projects and at team meetings
• Provide QA representation at multi-site disposition meetings
• Support and participate in inspections and audits
  
  

Basic Qualifications

Master’s Degree and 5 years of experience in GMP environment OR

Bachelor’s Degree and 7 years of experience in GMP environment OR

High School Degree and 11 years of experience in GMP environment

Preferred Qualifications

• Bachelor’s degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous situations
• Ability to understand risk and provide phase-appropriate appropriate decisions
• Ability to effectively negotiate and build collaboration amongst individuals
• Good interpersonal skills
• Strong written communication skills
• Strong analytical skills
• Comfortable in a fast-paced small company environment and operate with minimal direction
• Ability to adjust workload based upon rapidly changing priorities
  
  

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.