1+ months

Quality Assurance Associate

Kelly Services
Winston-Salem, NC 27199
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **temp-to-hire** opportunity to work as a **Quality Assurance Associate** located in **Winston Salem, NC** .

**Position Summary:**

Manages activities of the Manufacturing QA Batch Records and Deviations/CAPA organization. The Quality Assurance Associate coordinates and supports quality compliance programs under the direction of the Manager Quality Assurance to ensure compliance with laws, regulations and quality standards in relation to the company's GMP activities. Responsibilities include acting as the lead resource in the development and deployment of the site audits, and inspection readiness, management, and response.

**Essential Duties & Responsibilities:**

Support cGMP manufacturing operations for manufactured cell therapy products.

Provides overall direction to Quality Managers supporting master and executed batch record reviews/approvals for clinical and commercial programs, and the Deviation/CAPA system. Assures that department and company employees comply with required procedures.

Develop and/or support training materials for Quality Systems to include Deviation/CAPA system and batch record review.

Provide training and certification of QA personnel.

Level load work across teams to ensure batch records, Deviations and CAPAs in support of manufacturing and drug substance batch release timelines are achieved.

Functions as the Deviation/CAPA quality system owner.

Provides compliant investigations and review and approve compliant investigations as needed. Provides compliant review and approval of master batch records and manufacturing SOPs.

Support Manufacturing Change Controls as QA Subject Matter Expert, Supplemental Assessments and QA Approvals as required.

Track, trend, compile, and report client specific quality metrics as required. Specific data may be reported out at client meetings and internal Management Review meetings.

Supply data for Client Specific Annual Product Reports as needed.

Support Client Audits and Regulatory Inspections as required.

Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.

Work closely with Manufacturing to review and approve batch release

Work closely with Manufacturing to close out any and all deviation investigations and associated change controls

Manages large, complex projects and/or multiple smaller projects focusing on continuous improvement and/or quality culture step change

Monitors and reacts to site metrics to identify and lead improvement opportunities

Leads departmental projects including definition of acceptance criteria and success

Authors, reviews and approves technical documentation in support of cross-functional working team objectives

Provides operational support to other Quality System element owners as defined by management

Champions good documentation practices, data integrity compliance and site inspection readiness

Leads and/or participates in cross-functional teams to maintain system health and escalate barriers as required

Assess company's current inspection readiness status, propose and implement improvements, report status to Management

Plan and execute internal audits

**Education And Experience:**

0 - 2 years of relevant hands-on laboratory experience.

BS degree in Chemistry from an accredited college or university or a combination of equivalent education and applicable job experience.

**Knowledge, Skills, And Abilities**

Excellent observation skills and problem-solving abilities.

Ability to work in a methodical, organized, and creative fashion.

Ability to read, follow and under limited supervision, develop research protocols.

Ability to write in a concise and logical fashion in order to record all pertinent details of experimental procedures and data. In addition, ability to write reports for internal circulation on scientific results generated.

Ability to effectively utilize scientific information resources within the assigned areas of responsibility.

Ability to work effectively, both independently, and as an integral contributor toward the achievement of project and company goals.

Ability to manage multiple responsibilities, with a high degree of self-motivation.

Excellent observation skills and good problem-solving ability.

Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant technical information.

Skilled at promoting team cooperation and a commitment to team success.

Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.



**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-07-25 Expires: 2022-10-08

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Quality Assurance Associate

Kelly Services
Winston-Salem, NC 27199

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