Clinical

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:

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented.

Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve:

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.

The individual should be able to demonstrate the following:

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

Excellent written and verbal communication and interpersonal skills

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

Organizes and provides written and/or oral presentations of work with minimal input

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

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).

How You Will Achieve It

Act as a point of contact for Quality Assurance to support production

Demonstrate good decision-making skills

Demonstrate strong knowledge/understanding of the principles and concepts of aseptic technique and manufacturing 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 Pharmaceutical 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.

Qualifications:

Must-Have

Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year 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)

3+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Degree in Science/related field

Nice-to-Have

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

Physical or Mental Requirements:

Requires working on shop floor and in an office setting.

Computer usage would be typical. Ability to stand for 2-3 hours at a time, sit for 2 to 3 hours at a time, aseptically gown into manufacturing areas, and walk long distances.

Non-Standard Work Schedule, Travel or Environment Requirements:

Work schedule is primarily first shift during weekdays but may include weekends and second and/or third shift hours on occasion to support manufacturing operations activities. Ability to adhere to safe work practices and procedures such as aseptic gowning.

Limited travel for the position; no more than 5% traveling. Job requires majority on-site presence.

Day 2 Day:

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

Interview Process:

Virtual: Teams Panel