Senior Associate Manufacturing
Spectraforce
Thousand Oaks, California
3 hours ago
Job Description
Job Title: Senior Associate Manufacturing
Duration: 3+ months
Location: Thousand Oaks, CA, 91320
Description:
Exact Schedule - 8am-5pm M-F, OT is possible - fully onsite
In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
- Executing drug product filling activities
- Performing initial review of manufacturing batch records
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
- Crafting and/or revising standard procedures
- Leading continuous improvement initiatives, which may be multi-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, unit operations
- Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
- Elevating critical and impactful events to management
- Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
Top 3 Must Have Skill Sets:
- GMP Knowledge
- Project Management
- Cross Functional Team Building
Nice to have: Prior pharma, Data visualization skills, Excel
Day to Day Responsibilities:
The Senior Associate Manufacturing will be specifically responsible for:
- Executing drug product filling activities
- Performing initial review of manufacturing batch records
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
- Crafting and/or revising standard procedures
- Leading continuous improvement initiatives, which may be multi-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, unit operations
- Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
- Elevating critical and impactful events to management
- Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
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: $ 26.11/hr.
Duration: 3+ months
Location: Thousand Oaks, CA, 91320
Description:
Exact Schedule - 8am-5pm M-F, OT is possible - fully onsite
In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
- Executing drug product filling activities
- Performing initial review of manufacturing batch records
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
- Crafting and/or revising standard procedures
- Leading continuous improvement initiatives, which may be multi-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, unit operations
- Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
- Elevating critical and impactful events to management
- Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
Top 3 Must Have Skill Sets:
- GMP Knowledge
- Project Management
- Cross Functional Team Building
Nice to have: Prior pharma, Data visualization skills, Excel
Day to Day Responsibilities:
The Senior Associate Manufacturing will be specifically responsible for:
- Executing drug product filling activities
- Performing initial review of manufacturing batch records
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
- Crafting and/or revising standard procedures
- Leading continuous improvement initiatives, which may be multi-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, unit operations
- Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
- Elevating critical and impactful events to management
- Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
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: $ 26.11/hr.