Quality Assurance Senior Associate

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:

Quality Assurance Senior Associate

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.

Responsibilities:

Responsible for review/approval of change controls, Engineering Change Management Requests, and proceduralized change SOP documentation for computer systems/equipment/processes

Provide support for other QA functions, e.g. quality investigation review

Interface 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

Support 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

Act as SME for department to support site audits/inspections

Interface with other parts of the organization such as Global Quality Operations groups and Pharmaceutical Research and development groups.

Qualifications:

Bachelor's degree with a minimum 3+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry OR;

Master's degree with a minimum of 1+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry

Previous experience with change management is beneficial

Experience with Drug Substance and Drug Product commercial manufacturing preferred

Experience with Standard Operating Procedures (SOP)

Experienced and proficient with Microsoft Word and Excel

Document management system experience

Ability to act as a team player with strong interpersonal skills

Location:

This is a fully onsite position in Sanford, NC