QA Document ControlRelease

NO EXTERNAL RECRUITERS PLEASE

**No Sponsorship/Transfer Available**

Company Summary:

For over 60 years MeriCal has been at the forefront of innovation in the dietary supplement industry delivering custom manufacturing and packaging solutions with passion and precision. With state-of-the-art facilities in Southern California and Ogden UT we transform ideas into high-quality productsfrom research and development to the finished products. Our team with over 230 years of combined experience is dedicated to crafting exceptional gummies probiotics tablets capsules chewables and powders using clinically backed ingredients. At MeriCal we dont just meet expectationswe exceed them every time. Join us and be part of a dynamic forward-thinking team shaping the future of nutrition!

The Opportunity:

The Document Control Specialist is detail-orientated and computer proficient. The Document Control Specialist is responsible for maintaining and managing all controlled documents within the Quality Management System (QMS) to ensure compliance with FDA regulations under 21 CFR Parts 111 (Dietary Supplements) 117 (Food Safety) and 210-211 (Drug GMPs). This individual will be a key member of Quality Assurance team leading change control operations managing and maintaining controlled documents that support our cGMP quality operations.

What Youll Do:

• Maintain and manage controlled documents including Standard Operating Procedures (SOPs) CAPAs deviation records batch records specifications controlled forms calibration certificates training records logbooks and qualification records.
• Maintain a current master index of all controlled documents and ensure distribution lists are up to date.
• Process document change requests revisions approvals and archival in accordance with internal SOPs.
• Maintain both paper and electronic based records.
• Manager transition of paper-based records to electronic records.
• Maintain master has copies of all controlled documents ensuring proper labeling version control and protection from damage or loss.
• Ensure SOPs and associate forms are current and initiating change control procedures as needed.
• Coordinate with Quality Assurance R&D Regulatory Manufacturing and other departments to ensure timely review and release of documents.
• Responsible for learning and maintaining electronic document control quality management systems including being a system administrator and subject matter expert.
• Ensure all documentation is organized version-controlled accessible to appropriate stakeholders and backed up securely.
• Conduct periodic document audits to ensure accuracy completeness and regulatory compliance.
• Train staff on document control procedures and proper use of the change control program.
• Support internal and external audits by providing necessary documentation in a timely and organized manner.
• Assist in continuous improvement initiatives related to document control and quality systems.
• Conduct new hire cGMP on-boarding training create evaluation tests issue job-specific curriculums scheduled and deliver cGMP Annual Training and Food Safety training curriculum.
• Supports and trains all employees on Quality issues in their roles to assure compliance to regulations track training progress via training matrix.
• Understand cGMP requirement as they relate to Quality Assurance.
• Help assist in QA functions related to customer documentation request.
• Manager KPI metrics.
• Review calibration results and document the review support maintenance with updating the master calibration list in the maintenance software program.
• Assist in coordinating the production operation to ensure batch records are issues to the floor prior to production needs.
• Assist in supplier qualification programs.
• Assist in Quality Assurance operations related to customer and regulatory audits.
• Assist in pre-audit and questionnaire completion GMP Certs Licenses and Registrations etc.
• Perform other duties as assigned.

What Youll Bring:

• Minimum High School diploma Bachelors degree preferred.
• Minimum of 3 years of experience related to quality in an industry regulated by 21 CFR Parts/211. Part 111 highly preferred.
• Strong project management skills experience leading cross-functional teams and the ability to handle multiple projects simultaneously is a must.
• Excellent verbal and written communication understand instructions in English.
• Ability to work independently with limited supervision.
• Advanced proficiency with Microsoft Office Suite and other related software.
• Familiar with ERP Systems (SAGE) and Quality Management Systems such as ETQ Reliance Trackwise MasterControl.

The Perks:

• No-cost vision insurance (yes you read that right!) employer-paid life insurance paid company holidays generous paid time off sick leave employee assistance program and a comprehensive wellness program.
• Affordable medical and dental insurance plans tailored for you and your dependents.
• Exceptional supplemental benefits including Accident Critical Illness Hospitalization indemnity plans and pet insurance.
• 401(k) matching plan and more!

A reasonable estimate of the current base pay range for this position is $27.00 to $34.00. The compensation offered may vary depending on the candidates geographic region job-related knowledge skills and/or education.

MeriCal is an equal opportunity employer and is committed to providing a workplace that is inclusive and free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status protected veteran status or any other characteristic protected by law. We encourage individuals of all backgrounds to apply. We believe in creating a diverse and inclusive workplace where all employees feel valued and respected and where differences are embraced as strengths. We are dedicated to fostering an environment that promotes equality and celebrates diversity.

Qualified applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and/or certain state or local laws. Please contact if you need an accommodation due to a disability to complete an application job interview and/or to otherwise participate in the hiring process. This email does not respond to non-accommodations related requests.

MeriCal uses E-Verify to confirm authorization to work in the United States. For more information on E-Verify please visit the following website: more information about the categories of personal information we collect from you and how we use sell and share that information please see our Privacy Notice for California Contractors and Privacy Notice for California Employees.