Quality Assurance Associate

Position Details:

Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Senior Quality Assurance Associate to join their expanding team.

Job Title: Senior Quality Assurance Associate / 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 Associate

Summary:

The site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.

This position will support the Manufacturing Quality Assurance department by performing Quality activities associated with Gene Therapy (GTx) manufacturing operations.

You will be responsible for performing the following Quality Assurance (QA) responsibilities: batch disposition activities, manufacturing shop floor support including aseptic observations, investigation approval, change control approval, product and material release, complaints handling, Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval.

In addition, the position will be responsible for ensuring alignment with the Manufacturing Clinical and Commercial Quality Operations role.

As a GTx Quality Assurance Associate, your knowledge and skills will contribute towards the goals and objectives of the team.

This includes demonstrating independent decision-making in support of manufacturing. Strong communication skills are required to facilitate explaining difficult issues and achieving consensus between teams.

Responsibilities:

Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance

Review and Approval of SOPs, Batch Records, and Sample Plans

Perform and document Aseptic Observations of manufacturing processes (including Media Fills and Smoke Pattern Testing) and practices

Perform shop floor QA inspection and walk through for changeover and shutdown activities

Complete AQL for drug product filling operations

Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team

Suggest improvements and conduct continuous improvement activities

Maintain regulatory compliance in accordance with current Good Manufacturing Practices part of GxP practices

Provide Quality review and oversight of site cGxP documentation related to the operation of a Gene Therapy manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical Quality Standards

Provide Quality support on the shop floor by maintaining presence during manufacturing operations, providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.), and conducting visual inspection for Drug Product operations

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

Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing

Provide manufacturing floor support that may include occasional weekends and second and/or third shift hours. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pharmaceutical expectations

Participates in activities/projects to support work group/project team goals

Approve SOPs, forms, protocols, change controls, and risk assessments (facilitator and/or team member).

Minimum Qualifications:

Applicant must have a minimum of 8+ years of relevant experience; OR an Associate's degree with a minimum of 6+ years of experience; OR a Bachelor's degree with a minimum of 3+ years of experience; OR a Master's degree with a minimum of 1+ years of experience

Knowledge of current Good Manufacturing Practices and applicable GxP regulations and standards

Proactive approach and strong critical thinking skills

Must be able to work in a team environment within own team and interdepartmental teams

Excellent communication, decision-making and interpersonal skills

Good working knowledge of Microsoft Excel and Word

Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)

Demonstrate knowledge of and adherence to EH&S safety requirements for site

Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts

Good foundation in general scientific practice and principles

Ability to organize and track status of assigned actions across multiple production areas

Ability to follow written procedures and learn from hands-on training

Preferred Qualifications:

Previous experience with a startup facility and developing Quality Operations processes is beneficial

Experience with Drug Substance and Drug Product clinical/commercial manufacturing preferred

Preferred experience with aseptic practices, investigations, and disposition activities

Willing to lead by example and be a collaborative and active listener

Effectively manages stressful situations, able to focus on tasks

Hours:

This is a fully onsite role in Sanford, NC

Work schedule is primarily first shift during weekdays, but may include weekends and second and/or third shift hours on occasion to support manufacturing operation activities

Minimal travel required for this position, no more than 5% traveling