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Specialist Manufacturing

Aditi Consulting

Thousand Oaks, CA

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JOB DETAILS
SALARY
$40–$41.16 Per Hour
SKILLS
Artificial Intelligence (AI), Automotive Automation, Biotech and Pharmaceutical, Change Control, Change Management, Communication Skills, Consulting, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Drug Products, GMP (Good Manufacturing Practices), Leadership, Maintain Compliance, Management Strategy, Manufacturing, Messaging Technology, Metrics, Multitasking, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Product/Service Launch, Project/Program Management, Purchasing/Procurement, Quality Assurance, Regulations, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Team Player, Technical Leadership, Technical Writing, Telephony, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago
Payrate: $40.00 - $41.16/hr.
 
Summary:
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? Our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best to work alongside other innovative, driven professionals in this meaningful role.
 
Responsibilities:
  • Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
  • Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
  • Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
  • Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
  • Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
  • Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
  • Representing the team at plant-wide and network-wide forums, as needed.
 
Preferred Qualifications:
  • Project Management experience
  • Direct and/or indirect people management / leadership experience
  • Understanding of Drug Product Formulation and Vial/Syringe Filling operations
  • Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
  • Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
  • Independent, self-motivated, able to multi-task in a fast-paced environment
  • Team-player
  • Demonstrated flexibility and ability to manage change
  • Direct experience with regulated environments (e.g., cGMP etc.)
 
Must Have Skills:
  • Cross functional project management experience
  • Change control experience in a GMP environment
  • Demonstrated independent problem-solving ability
  • Drug Product Manufacturing Experience
 
Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 - $41.16 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy .
 
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Aditi Consulting