Quality/Operations - Document Control

New
  • Location
    San Marcos , California
  • Category
    Medical & Science - Pharmaceutical - Clinical
  • Job type
    Direct Hire

Adecco Medical and Science is currently recruiting for a Quality/Operations Specialist with strong Ducument Control skills for our San Diego location.


Quality/Operations Specialist Nutraceutical/Pharmaceutical


Summary:


Provide quality and technical expertise, regulation interpretation and recommendations to leadership team including but not limited to gap analysis and improvements on existing programs and processes and/or new programs and processes as needed to ensure regulatory compliance and optimal business efficiencies. Responsible for updates within Salesforce CRM and development of various initiatives including, but not limited to, developing reports, dashboards, and supporting the organization’s aggressive growth goals. Responsible for supporting operations team with daily deadlines surrounding orders and/or customer requests.

Essential Duties & Responsibilities:


Operations

Review manufacturer Certificate of Analysis for accuracy; prepare company Certificate of Analysis on company letterhead; develop customer specific COA templates if required
Reviews all customer requirements (product and shipping) ensures requirements are noted in Salesforce
Ensures accuracy with all inbound inventory orders, outbound customer order shipments, regulatory and quality documentation
Provide easy to interpret Salesforce reporting on trends and pipeline performance
Responsible for receiving and outbounding inventory in ERP system on a daily basis
Responsible for assisting with order entry and customer follow up when necessary
Assist in executing the day-to-day operational activities as assigned including other duties as assigned

Quality

Responsible for establishing and maintaining quality program in compliance with federal, state and local regulations, including but not limited to FDA 21CFR 110, 111 117, FSMA, cGMPs, HACCP, etc.
Maintain and expand upon current Food Safety Plan with regards to regulatory, quality, company and customer requirements and standards
Works with Lead Scientist to develop and maintain SOP on vendor and material qualification program to include periodic requalification requirements as applicable
Ensure that our quality and food safety standards and compliance requirements are fully implemented and met by our suppliers
Maintain and manage quality and technical documentation such as Certificate of Analysis (COA), MSDS, Allergen Statements, and other required documents by product/manufacturer
Conduct investigations for customer complaints, including root-cause analysis, CAPA implementation and final disposition for each complaint/incident of non-conformance
Track and trend data, complaints, OOS, etc. for continuous improvement purposes
Complete customer quality questionnaires and supplier documents upon request
Maintain updated documentation and certifications such as Kosher, Halal, gluten-free, non-GMO and organic
Implement and maintain internal auditing program
Work with regulatory consultants and other subject matter experts as needed to complete job requirements
Enhance professional growth and development through participation in educational programs, current literature and workshops


Qualifications

Bachelor’s degree required, with at least 3-5 years’ experience in a quality and operations. Industry experience in food/dietary supplements and/or sports nutrition preferred
Preventative Controls Qualified Individual Preferred (PCQI certified)
Salesforce experience preferred
Must have broad business knowledge and database management experience. Knowledge of sales processes, policies, and procedures
Previous experience implementing HACCP, Food Safety, cGMPs, FDA 21CFR Part 110, 111, 117 and FSMA
Ability to present technical and business solution concepts to all levels (including non-technical audiences)
Must excel and be effective and professional in written and verbal forms of communication
Must be computer literate and able to demonstrate proficiency in MS Word, Excel, PowerPoint, Outlook
Must possess the following characteristics: organized, detail oriented, time management, problem solver, self-motivator, and multi-tasker
Must have a high level of awareness and interpersonal intelligence with an ability to “read between the lines” and give the client what they need, not just what they ask for
Establishes and maintains honest, effective relationships with employees at all levels in the organization and gains their trust and respect. Accessible, a good listener and put others at ease at all times. Develops a reputation for being dependable, sincere, and trustworthy
Must maintain confidentiality of company financial and other sensitive and proprietary information

If you are interested in this Quality/Operations Specialist job in San Diego, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at Randy.Williamson@adeccona.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_108175_320529