Total 9 Associate Editor job vacancies in Quality Assurance / Control category in The United States of America

Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform a 12-hour shift (full night shift preferably).

Responsibilities:

• Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
• Participate in on the floor triage and support root cause investigations for major investigation if applicable
• Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
• Escalate any significant event to Quality management in a timely manner

About You:

• Bachelor’s Degree in Science or engineering related
• 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Fresh graduates are welcome to apply.
• Direct experience with bulk manufacturing of biopharmaceuticals preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Fluency in written and spoken English
• Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern

Salary : S$3000 - 5000

Duration : 1 year contract. Option to extend/annual renewal depending on performance

Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform a 12-hour shift (full night shift preferably).

Responsibilities:

• Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
• Participate in on the floor triage and support root cause investigations for major investigation if applicable
• Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
• Escalate any significant event to Quality management in a timely manner

About You:

• Bachelor’s Degree in Science or engineering related
• 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Fresh graduates are welcome to apply.
• Direct experience with bulk manufacturing of biopharmaceuticals preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Fluency in written and spoken English
• Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern

Salary : S$3000 - 5000

Duration : 1 year contract. Option to extend/annual renewal depending on performance

Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform a 12-hour shift (full night shift preferably).

Responsibilities:

• Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
• Participate in on the floor triage and support root cause investigations for major investigation if applicable
• Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
• Escalate any significant event to Quality management in a timely manner

About You:

• Bachelor’s Degree in Science or engineering related
• 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Fresh graduates are welcome to apply.
• Direct experience with bulk manufacturing of biopharmaceuticals preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Fluency in written and spoken English
• Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern

Salary : S$3000 - 5000

Duration : 1 year contract. Option to extend/annual renewal depending on performance

Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform a 12-hour shift (full night shift preferably).

Responsibilities:

• Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
• Participate in on the floor triage and support root cause investigations for major investigation if applicable
• Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
• Escalate any significant event to Quality management in a timely manner

About You:

• Bachelor’s Degree in Science or engineering related
• 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Fresh graduates are welcome to apply.
• Direct experience with bulk manufacturing of biopharmaceuticals preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Fluency in written and spoken English
• Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern

Salary : S$3000 - 5000

Duration : 1 year contract. Option to extend/annual renewal depending on performance

Responsibilities:

• Main responsibilities include overseeing batch record review and incoming material quality audit.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Ensure site and global quality compliance.
• All other responsibilities of QA Ops related.
• Any other task as assigned by Supervisor/Manager.

About You:

• Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply.
• Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Relevant QA Operations background from pharma or biotech environment is preferred
• Familiar with Health Authorities standards (e.g., FDA CFR and EU)
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.

Responsibilities:

• Main responsibilities include overseeing batch record review and incoming material quality audit.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Ensure site and global quality compliance.
• All other responsibilities of QA Ops related.
• Any other task as assigned by Supervisor/Manager.

About You:

• Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply.
• Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Relevant QA Operations background from pharma or biotech environment is preferred
• Familiar with Health Authorities standards (e.g., FDA CFR and EU)
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.

Responsibilities:

• Main responsibilities include overseeing batch record review and incoming material quality audit.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Ensure site and global quality compliance.
• All other responsibilities of QA Ops related.
• Any other task as assigned by Supervisor/Manager.

About You:

• Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply.
• Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Relevant QA Operations background from pharma or biotech environment is preferred
• Familiar with Health Authorities standards (e.g., FDA CFR and EU)
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.

Responsibilities:

• Main responsibilities include overseeing batch record review and incoming material quality audit.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Ensure site and global quality compliance.
• All other responsibilities of QA Ops related.
• Any other task as assigned by Supervisor/Manager.

About You:

• Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply.
• Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Relevant QA Operations background from pharma or biotech environment is preferred
• Familiar with Health Authorities standards (e.g., FDA CFR and EU)
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.

Responsibilities:

• Main responsibilities include overseeing batch record review and incoming material quality audit.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Ensure site and global quality compliance.
• All other responsibilities of QA Ops related.
• Any other task as assigned by Supervisor/Manager.

About You:

• Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply.
• Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Relevant QA Operations background from pharma or biotech environment is preferred
• Familiar with Health Authorities standards (e.g., FDA CFR and EU)
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.