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Senior Specialist of Quality Operations
Job Description
Target PR Range: 44-54/hr
*Depending on experience
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 Masters Degree and 5+ years of experience in GMP environment OR Bachelors Degree and 7+ years of experience in GMP environment OR High School Degree and 11+ years of experience in GMP environment
Preferred Qualifications
- Bachelors 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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