quality assurance associate.

　　sanford , north carolina

　　posted 2 days ago

　　job details

　　summary

　　$36.32 - $45.65 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47283

　　job details

　　job 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.

　　location: Sanford, North Carolina

　　job type: Contract

　　salary: $36.32 - 45.65 per hour

　　work hours: 8 to 4

　　education: Bachelors

　　responsibilities:

　　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 company 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 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 company 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.

　　skills: Quality control, SOP, Quality Assurance, Biology, Chemistry, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System

　　Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.