Manager, Quality Assurance

International Vitamin Corporation; Parkins Lake (SC); On-site; USD 85,000 - 125,000; Full time

Job summary

International Vitamin Corporation (IVC) is seeking a Senior Quality Assurance leader to oversee day-to-day QA operations, audits, document control, GMP training, and SOP development in the production of dietary supplements and related products.

The role requires a Bachelor’s degree in a scientific/engineering field plus 2–5 years of experience, with 5–10 years in quality systems and at least 3 years in a supervisory capacity. Expertise in cGMP guidelines and 21 CFR parts 110/111 is expected.

Qualifications

• Bachelor’s degree in a Scientific or Engineering discipline with exposure to Chemistry, Microbiology, and/or Biology.
• 2–5 years of experience; 5–10 years with supervisory role in quality systems in dietary supplements/pharmaceutical manufacturing.
• Professional quality discipline certifications (CQE, CQA, PCQI) desired.

Responsibilities

• Enforce GMP compliance across the organization and with 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 SOPs.
• Lead external audits and coordinate CAPA responses; prepare audit reports and monitor CAPA sustainability.
• Prepare quality reports and discuss quality issues with operations monthly.
• Oversee the GMP squad and collaborate with all departments to ensure program effectiveness.
• Perform additional tasks or special projects as assigned by senior Quality Management.

Skills

Quality management

GMP knowledge

Leadership/ Supervisory

Communication

English proficiency

Education

Bachelor’s degree in a Scientific or Engineering discipline

Exposure to Chemistry, Microbiology, or Biology

Professional quality discipline certifications (CQE, CQA, PCQI) desired

Tools

Microsoft Office

Job description

Overview

Position Overview

Responsible for overseeing the day-to-day operations of the Quality Assurance Department including internal and external audit, document control, compliance, GMP training, 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.

Responsibilities

Specific 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).
• Participate and or lead 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.
• Prepares quality reports and conducts monthly meetings with the operations group to discuss quality issues and improvements.
• Oversee the GMP squad and collaborate with all functional departments to ensure effectiveness of the program
• Perform additional tasks or special projects as assigned senior Quality Management.

General Responsibilities

• 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 elements as contained herein between the assigned start and end times for work.
• Performs such individual assignments as management may direct.
• Other duties as assigned.

Qualifications

The Candidate

Education, Experience, and Licenses:

• Bachelor’s Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology, and/or Biology, in a related field, or equivalent job experience
• 2 -5 years of experience
• Professional quality discipline certifications (CQE, CQA, PCQI, etc.) desired
• Minimum 5-10 years of experience establishing and maintaining quality systems in the Dietary Supplements and/or pharmaceutical manufacturing industry with 3+ years in a Supervisory role.

Knowledge, Skills, and Abilities

• 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

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer.

Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.