Manufacturing Specialist (100% Remote)
Spectraforce
Thousand Oaks, California
4 days ago
Job Description
Position Title: Specialist Manufacturing
Work Location: 100% Remote
Assignment Duration: 12 months
Work Arrangement: Remote - Flexible hours, 40 hours per week with potential overtime
Position Summary: Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
Background & Context:
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
What you will do
Let’s do this! Let’s change the world!
Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
What we expect of you
Preferred Qualifications:
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.
Work Location: 100% Remote
Assignment Duration: 12 months
Work Arrangement: Remote - Flexible hours, 40 hours per week with potential overtime
Position Summary: Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
Background & Context:
- Supplement additional workload on team.
Top 3 Must Have Skill Sets:
- Experience with operations and Quality systems
- Facilitating meetings with cross-functional teams
- Experience with finance managing budgets, PO's, and forecasts
Day to Day Responsibilities:
- Quality record management for Change Controls, Deviations, Complaints, and CAPA's internally and with our partner contract manufacturing organizations.
- Financial oversight of specific programs within our external supply network.
- Facilitation of cross-functional team meetings to track actions, key performance indicators, and ensure other key deliverables are being met.
- Project management and Tech Transfer Activities.
Basic Qualifications:
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
What you will do
Let’s do this! Let’s change the world!
Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
- Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
- Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
What we expect of you
- We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborator with these qualifications.
Preferred Qualifications:
- Bachelor’s in Business Administration, Engineering, or Science-related field.
- 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
- 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
- 2+ years of project management experience leading multi-functional and/or multi-location team.
- 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
- Manufacturing and cGMP knowledge / experience. Financial knowledge and business acumen.
- Budget management, including purchase orders, financial forecasting, and adhering to financial targets and systems.
- Demonstrated matrix management and influencing skills. Demonstrated negotiation skills.
- Operational Excellence proficiency and ability to drive continuous improvement.
- Proficient project management skills. Problem-solving and critical thinking.
- Understanding of contractual requirements. Technical writing and multi-level communication skills.
- Demonstrated ability to lead effectively in collaborative/team environment.
- Demonstrated ability to take initiative, drive action, and work under minimum supervision
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.