Clinical

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 Client 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 Client'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 Client 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

Position Comments visible to MSP and Supplier:

Request: Clinical-Scientific - Quality Assurance - Clinical

Number of Contractors Needed: 1

Candidate Submission Limit Per Supplier: 2

Desired Start Date: 2/19/2024

Hrs/Wk: 40.00

MSP Owner: Brock, Heather

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."