Manager, Quality Assurance

International Vitamin Corporation•Greenville, SC

9d•Onsite

About The Position

Responsible for overseeing the day-to-day operations of the Quality Assurance Department including internal and external audit, document control, compliance, GMP training, complaints, SOP (standard operating procedures) development and control, and other related programs and identify continuous improvement activities to enhance and sustain GMP compliance in the production of Dietary Supplements and other IVC (International Vitamin Corporation) products.

Requirements

Bachelor’s degree in a related field or equivalent job experience
2-5 years of experience
Computer literate and familiar with commercial software such as Microsoft Office: Word, Excel, Access and PowerPoint
Knowledge of 21 CFR 110 and 111 quality regulations and current Good Manufacturing Practices (cGMP) guidelines
Capability to work in a manufacturing environment with air-borne powder, noise, and moving equipment
Able to communicate, write and understand English.
Ability to sit, walk, stand, and reach frequently

Responsibilities

Enforce GMP compliance in the organization and other strategic partners.
Review and assist in developing the quality system policies and procedures.
Maintain and implement the company’s quality system policies and procedures.
Develop, update, and maintain the company’s standard operating procedures (SOP’s) in ensure.
Participate and or lead internal and external audits and coordinate functional groups with the development of their corrective and preventive action (CAPA) responses, prepare audit reports and monitor sustainability of identified CAPA’s.
Oversee the customer complaint registry and ensure CAPA’s are submitted to the customer in a timely manner.
Supervise the activity of the compliance and validation team.
Prepares quality reports and conducts monthly meetings with the operations group to discuss quality issues and improvements.
Develop and implement process, equipment, and cleaning validation/verification program.
Oversee the GMP squad and collaborate with all functional departments to ensure effectiveness of the program
Perform additional tasks or special projects as assigned by the V.P. of Quality and Regulatory Affairs.
Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.
Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.
Performs such individual assignments as management may direct.
Other duties as assigned.