Trinity Consultants - Advent Engineering
Quality Control Subject Matter Expert (SME) – QC Instrumentation
Trinity Consultants - Advent Engineering, California, Missouri, United States, 65018
Quality Control Subject Matter Expert (SME) – QC Instrumentation
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Direct message the job poster from Trinity Consultants - Advent Engineering
Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
This is an outstanding opportunity to join our growing team!
Job Summary:
We are seeking an experienced
Quality Control Subject Matter Expert (SME)
to lead and manage a critical QC instrumentation project in the biotechnology/pharmaceutical industry. The ideal candidate will have in-depth knowledge of QC processes, as well as experience in managing the installation, commissioning, and qualification of QC instruments. You will interface with vendors, ensure proper operation of instruments, and assist in the qualification and validation processes in line with industry standards and regulatory requirements.
Key Responsibilities:
QC Instrumentation Management : Lead the installation, qualification, and maintenance of QC instruments in the lab, ensuring full compliance with industry and regulatory standards.
Vendor Interface : Act as the primary liaison between the company and equipment vendors to ensure timely installation, troubleshooting, and ongoing technical support.
Instrument Qualification : Assist in the validation and qualification of QC instruments, ensuring they meet required performance specifications and regulatory standards (e.g., GMP, FDA).
Troubleshooting & Maintenance : Oversee the troubleshooting, calibration, and preventive maintenance of QC instruments, ensuring minimum downtime and optimal performance.
Training & Support : Provide training and ongoing technical support to QC team members on the proper use and maintenance of instruments.
Documentation & Compliance : Ensure all instrument-related documentation, including calibration, qualification, and maintenance records, is accurately completed and stored in compliance with regulatory requirements.
Process Improvement : Identify opportunities for process optimization in instrument qualification and maintenance, contributing to continuous improvement initiatives.
Qualifications & Skills:
Education : Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s preferred).
Experience : Minimum of 10 years of experience in Quality Control within the biotechnology or pharmaceutical industry, with a focus on QC instrumentation and qualification.
Technical Expertise : Strong knowledge of QC instruments and their role in analytical testing (e.g., HPLC, spectrophotometers, pH meters, etc.).
Regulatory Knowledge : Familiarity with GMP, FDA, and other relevant regulatory requirements in the pharmaceutical or biotechnology sector.
Project Management : Experience managing projects, including the coordination of timelines, resources, and vendor interactions.
Problem-Solving Skills : Strong troubleshooting skills for diagnosing and resolving equipment and process issues.
Communication : Excellent communication skills, with the ability to collaborate with cross-functional teams and vendors.
Attention to Detail : High level of attention to detail, especially with documentation and compliance-related tasks.
Preferred Qualifications:
Certification in Quality Control, Project Management, or a related field.
Experience with computerized systems validation (CSV) and instrument qualification tools.
Knowledge of industry trends and emerging technologies in QC instrumentation.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting and Engineering
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Trinity Consultants - Advent Engineering by 2x
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Direct message the job poster from Trinity Consultants - Advent Engineering
Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
This is an outstanding opportunity to join our growing team!
Job Summary:
We are seeking an experienced
Quality Control Subject Matter Expert (SME)
to lead and manage a critical QC instrumentation project in the biotechnology/pharmaceutical industry. The ideal candidate will have in-depth knowledge of QC processes, as well as experience in managing the installation, commissioning, and qualification of QC instruments. You will interface with vendors, ensure proper operation of instruments, and assist in the qualification and validation processes in line with industry standards and regulatory requirements.
Key Responsibilities:
QC Instrumentation Management : Lead the installation, qualification, and maintenance of QC instruments in the lab, ensuring full compliance with industry and regulatory standards.
Vendor Interface : Act as the primary liaison between the company and equipment vendors to ensure timely installation, troubleshooting, and ongoing technical support.
Instrument Qualification : Assist in the validation and qualification of QC instruments, ensuring they meet required performance specifications and regulatory standards (e.g., GMP, FDA).
Troubleshooting & Maintenance : Oversee the troubleshooting, calibration, and preventive maintenance of QC instruments, ensuring minimum downtime and optimal performance.
Training & Support : Provide training and ongoing technical support to QC team members on the proper use and maintenance of instruments.
Documentation & Compliance : Ensure all instrument-related documentation, including calibration, qualification, and maintenance records, is accurately completed and stored in compliance with regulatory requirements.
Process Improvement : Identify opportunities for process optimization in instrument qualification and maintenance, contributing to continuous improvement initiatives.
Qualifications & Skills:
Education : Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s preferred).
Experience : Minimum of 10 years of experience in Quality Control within the biotechnology or pharmaceutical industry, with a focus on QC instrumentation and qualification.
Technical Expertise : Strong knowledge of QC instruments and their role in analytical testing (e.g., HPLC, spectrophotometers, pH meters, etc.).
Regulatory Knowledge : Familiarity with GMP, FDA, and other relevant regulatory requirements in the pharmaceutical or biotechnology sector.
Project Management : Experience managing projects, including the coordination of timelines, resources, and vendor interactions.
Problem-Solving Skills : Strong troubleshooting skills for diagnosing and resolving equipment and process issues.
Communication : Excellent communication skills, with the ability to collaborate with cross-functional teams and vendors.
Attention to Detail : High level of attention to detail, especially with documentation and compliance-related tasks.
Preferred Qualifications:
Certification in Quality Control, Project Management, or a related field.
Experience with computerized systems validation (CSV) and instrument qualification tools.
Knowledge of industry trends and emerging technologies in QC instrumentation.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting and Engineering
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Trinity Consultants - Advent Engineering by 2x
#J-18808-Ljbffr