Job Title: Operations Compliance Specialist
Location: San Diego, CA- ONSITE
Duration: 3 months and may lead to temp to hire
Pay: $43.00/HR 
Shift: MON-FRI 8AM – 4:30PM 

Position Overview:
The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective Action, Preventative Actions (CAPA’s) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the specialist drives root cause analysis, leads cross-functional problem-solving sessions, and develops SOPs and work instructions to strengthen operational standards.

Essential Functions:
• Participate in and facilitate Rapid Response Team fact gathering
• Write Investigation reports – These written reports will clearly communicate what happened, why it happened, when it happened
• Propose CAPAs – how to prevent event from happening in the future
• Deploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem-solving events
• Author SOPs and work instructions
• Review investigation documentation for Out Of Specifications, Out Of Trend or atypical results, as well as deviations from regulations, corporate policy or site procedures
• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner
• Communicates clearly with internal and external clients, both verbal and written
• Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks
• All other duties as assigned
Position Requirements:

Education or Experience:
• Bachelor’s degree required.
• Minimum of 5 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical knowledge and experience.
• Minimum of 3 years of technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GMP environment

Knowledge/Skills Requirements:
• Lean, Six Sigma, SPC experience (1 year preferred)
• Excellent oral and written communication skills
• Proactive problem-solving and analytical skills
• Self-motivated, disciplined, focused, work well under pressure and be able to prioritize work
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time
• Strong knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
  

• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  

• Access to more than 3,000 online training courses through our Kelly Learning Center
  

• Weekly pay and service bonus plans
  

• Group-rate insurance options available immediately upon hire*

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