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8 days old

Quality Assurance Technician

Kelly Services
Raleigh, NC 27608
The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Mallinckrodt requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Writes OOS and minor investigations. Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives.


**ESSENTIAL FUNCTIONS:**

1. Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.

2. Perform required QA inspections. (i.e Sample defect detection)

3. Perform the QA review and approval of executed Production batch records real-time (RTR).

4. Perform QA review for completed Sterilization records and associated documentation.

5. Ability to participate in internal audits, as requested.

6. Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.

7. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.

8. Assist personnel in the generation of operations/packaging area related exceptions.

9. Support investigations for minor classified exceptions.

10. Attend daily operations staff communication meetings.

11. Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.

12. Participate as a team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as, area inspections pre/post activity.

13. Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.

14. Ability to support the QA label release functions on an as needed basis.


**DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:**

1. Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.

2. Other duties as assigned with or without accommodation.


**Education required/ preferred:**


Associates degree in Science/Business preferred or equivalent industry experience. Bachelors degree in life sciences is a plus.


**Experience:**


Minimum 2 years of experience in a pharmaceutical QA/MFG environment is desired.


**Preferred Skills/Qualifications:**


ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred); previous experience in investigation root cause analysis and/or writing (preferred).


**Skills/Competencies:**


Ability to work in fast paced environment; Ability to adjust work schedule to meet operations and customer demand; Must be able to wear appropriate personal protective equipment to insure safe execution of job responsibilities.


**Other Skills:**


Skilled competency with computers, MS Office software required.

Experience with pharmaceutical CAPA and Documentation systems (e.g., Trackwise, Metric Stream, etc.) is preferred.




**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** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-11-19 Expires: 2021-12-20

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Quality Assurance Technician

Kelly Services
Raleigh, NC 27608

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