Clinical-Scientific - Quality Assurance - Clinical - Pioneer Data Systems
Sanford, NC 27330
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Quality Assurance Associate to join their expanding team.
Job Title: Quality Assurance Associate / Change Management / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 months
Location: Sanford, NC
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position Summary:
The position will support the Sanford, NC Quality Systems and Compliance department by performing Quality Assurance activities associated with clinical and/or commercial product.
Key responsibilities are performing Quality review/approval of clinical and/or commercial change management documentation for facilities/equipment/processes; planning and executing monthly/quarterly reports; suggesting improvements and conducting continuous improvement activities; and providing guidance/coaching to less experienced colleagues.
In addition, the position will be responsible for ensuring alignment with the Vaccines Quality Systems roles.
The successful candidate will be responsible for developing processes and procedures to perform these responsibilities.
This will require working collaboratively with cross-functional groups within the facility, at the Sanford site and across the Pharmaceutical network.
Position Responsibilities:
Responsible for review/approval of change controls, Engineering Change Management Requests, and proceduralized change SOP documentation for computer systems/equipment/processes.
Provides support for other QA functions, e.g. quality investigation review.
Interfaces with the Manufacturing Quality Operations team to ensure consistent approaches and sharing of best practices.
Responsible for knowing, understanding, role modeling, and ensuring others follow Pharmaceutical's values and culture.
Supports initiatives that contribute to building and strengthening the quality culture within the Facility. Practices and encourages quality cultural behaviors within both Quality and business lines.
Acts as SME for department to support site audits/inspections.
Interfaces with other parts of the organization such as Global Quality Operations groups and Pharmaceutical Research and development groups.
Qualifications:
3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
Previous experience with change management is beneficial.
Experience with Drug Substance and Drug Product commercial manufacturing preferred.
Organizational Relationships:
Manufacturing Quality Operations team
Engineering Team
Global Quality Operations
Education And Experience:
3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
Required
1. SOP
2. Previous exp
3. Word, Excel
4. Document management systems.
Preferred Skills:
1. Team Player
2. Interpersonal skills
Interview Process:
1 round Virtual via Teams
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Quality Assurance Associate to join their expanding team.
Job Title: Quality Assurance Associate / Change Management / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 months
Location: Sanford, NC
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position Summary:
The position will support the Sanford, NC Quality Systems and Compliance department by performing Quality Assurance activities associated with clinical and/or commercial product.
Key responsibilities are performing Quality review/approval of clinical and/or commercial change management documentation for facilities/equipment/processes; planning and executing monthly/quarterly reports; suggesting improvements and conducting continuous improvement activities; and providing guidance/coaching to less experienced colleagues.
In addition, the position will be responsible for ensuring alignment with the Vaccines Quality Systems roles.
The successful candidate will be responsible for developing processes and procedures to perform these responsibilities.
This will require working collaboratively with cross-functional groups within the facility, at the Sanford site and across the Pharmaceutical network.
Position Responsibilities:
Responsible for review/approval of change controls, Engineering Change Management Requests, and proceduralized change SOP documentation for computer systems/equipment/processes.
Provides support for other QA functions, e.g. quality investigation review.
Interfaces with the Manufacturing Quality Operations team to ensure consistent approaches and sharing of best practices.
Responsible for knowing, understanding, role modeling, and ensuring others follow Pharmaceutical's values and culture.
Supports initiatives that contribute to building and strengthening the quality culture within the Facility. Practices and encourages quality cultural behaviors within both Quality and business lines.
Acts as SME for department to support site audits/inspections.
Interfaces with other parts of the organization such as Global Quality Operations groups and Pharmaceutical Research and development groups.
Qualifications:
3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
Previous experience with change management is beneficial.
Experience with Drug Substance and Drug Product commercial manufacturing preferred.
Organizational Relationships:
Manufacturing Quality Operations team
Engineering Team
Global Quality Operations
Education And Experience:
3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
Required
1. SOP
2. Previous exp
3. Word, Excel
4. Document management systems.
Preferred Skills:
1. Team Player
2. Interpersonal skills
Interview Process:
1 round Virtual via Teams
Source : Pioneer Data Systems