Job Description

Location: Raleigh, NC

Direct Hire Opportunity

Salary: $70-$75/k

Essential Functions & Responsibilities:

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

· Perform required QA inspections; i.e Sample defect detection.

· Ability to participate in internal audits, as requested.

· 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.

· 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.

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

· Have the ability to support minor exceptions and simplified CAPAs and support phase II manufacturing investigations.

· Attend daily operations staff communication meetings.

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

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

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

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

· Maintain active communication with customers to facilitate continuous process improvement.

· Identify, initiate, and implement process improvements within the Manufacturing and Quality areas.

· Oversee departmental projects to ensure associated timelines are met ahead of schedule.

· Ability to pass visual acuity exam for production and identification of quality product purposes.

Education, Experience, and/or Skill:

· Associates degree in Science/Business preferred or equivalent industry experience.

· Bachelor's degree in life sciences is a plus.

· Minimum 8- 10 years of experience in a pharmaceutical QA/MFG environment is desired.

· ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred).

· Previous experience in investigation root cause analysis and/or writing (preferred).

· Skilled competency with computers, MS Office software required.

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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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