Quality Consulting Group, LLC
JT648 - MCS SR. MANUFACTURING ASSOCIATE
Quality Consulting Group, LLC, Thousand Oaks, California, United States, 91362
Senior Manufacturing Associate
Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated, and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
Lead and execute CAPAs and EVs related to Biopharmaceutical manufacturing ensuring timely completion and documentation.
Identify and
implement continuous improvement opportunities
to enhance
process efficiency, quality, and safety.
Gather and
ensure quality CAPA Applicability responses.
Use project management tools and methodologies to plan, monitor, and report on CAPAs, EVs and project progress and outcomes.
Responsible for owning, executing and completing multiple CAPAs and EVs across multiple buildings.
Communicate effectively with internal and external partners, such as quality, engineering, validation, regulatory, and suppliers.
Adhere to all applicable policies, procedures, and standards, such as cGMP, SOPs, and EHS.
Ensure the right actions have been suggested, implemented and tested in a way that is audit robust, while ensuring eliminating repeat errors.
Qualifications
Bachelor’s degree in
Engineering, Science, or related field
3 years of Manufacturing or Operations experience
Basic Manufacturing knowledge
Project Management skills
CAPA experience would be a nice to have, not required.
Experience with CAPA and EV ownership and execution,
preferably using Veeva Systems or similar quality system.
Strong analytical, problem-solving, and decision-making skills
Ability to work independently and collaboratively, with a high level of initiative and accountability
Excellent verbal and written communication skills, with attention to detail and accuracy
Experience with project management tools and techniques, such as
MS Project, Agile, Smartsheet, or Lean Six Sigma. (preferred)
Shift:
1st shift (Mon – Fri)
Hybrid but must be local to Thousand Oaks.
Will be fully onsite in the beginning with opportunity to WFH some days after the first few months.
Location: Thousand Oaks, CA
#J-18808-Ljbffr
Responsibilities
Lead and execute CAPAs and EVs related to Biopharmaceutical manufacturing ensuring timely completion and documentation.
Identify and
implement continuous improvement opportunities
to enhance
process efficiency, quality, and safety.
Gather and
ensure quality CAPA Applicability responses.
Use project management tools and methodologies to plan, monitor, and report on CAPAs, EVs and project progress and outcomes.
Responsible for owning, executing and completing multiple CAPAs and EVs across multiple buildings.
Communicate effectively with internal and external partners, such as quality, engineering, validation, regulatory, and suppliers.
Adhere to all applicable policies, procedures, and standards, such as cGMP, SOPs, and EHS.
Ensure the right actions have been suggested, implemented and tested in a way that is audit robust, while ensuring eliminating repeat errors.
Qualifications
Bachelor’s degree in
Engineering, Science, or related field
3 years of Manufacturing or Operations experience
Basic Manufacturing knowledge
Project Management skills
CAPA experience would be a nice to have, not required.
Experience with CAPA and EV ownership and execution,
preferably using Veeva Systems or similar quality system.
Strong analytical, problem-solving, and decision-making skills
Ability to work independently and collaboratively, with a high level of initiative and accountability
Excellent verbal and written communication skills, with attention to detail and accuracy
Experience with project management tools and techniques, such as
MS Project, Agile, Smartsheet, or Lean Six Sigma. (preferred)
Shift:
1st shift (Mon – Fri)
Hybrid but must be local to Thousand Oaks.
Will be fully onsite in the beginning with opportunity to WFH some days after the first few months.
Location: Thousand Oaks, CA
#J-18808-Ljbffr