Cqa Jobs in Indiana (NOW HIRING)

Position Overview

Develops, implements, and maintains the activities of quality assurance systems. Oversees the Batch Records review and releases and implementation of standards, methods, and procedures for the in-line and/or off-line product attributes inspection/evaluation. Makes recommendations for corrective actions necessary to ensure conformity with quality specifications. Ensures finished products conform to government, company standards, and satisfy good manufacturing practices regulations

Specific Responsibilities

• Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including cost, methods, and staffing.
• Provides leadership, coaching and development plans for all direct reports to maintain and engaged and productive workforce; partnering with human resources on employee matters.
• Embrace company-wide policies and procedures. Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect.
• Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
• Establish standard and meaningful objectives and metrics that align to goals, mission, and objectives for applicable department/program.
• Develops and distributes metrics to support the business.
• Reports on key performance indicators associated with program effectiveness.
• Generally, manages department budget and day-to-day functions. Develops budgets, schedules, and performance standards. Exercises supervision in terms of cost, methods, and staffing.
• Ensures goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
• Interacts frequently with internal departments, particularly in problem resolution. Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary actions, and terminations.
• Remains current with industry standards and best practices to promote activities necessary for evolution of the quality management system.
• Ensures procedures are clearly defined and implemented to fulfill regulatory and business requirements. Identifies areas for continuous improvement of these procedures (best in class).
• Ensures documents are properly maintained, with good documentation practices, for all manufactured and distributed products, quality system processes, and applicable services.
• Keeps up-to-date on new regulations and standards that affect the program.
• Ensures the development and maintenance, as appropriate, of data collection and analysis systems including development, rationale, and review of product and process specifications.
• Ensures the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.
• Plan, administer, lead, and manage Audit program including internal and external audits, as well as regulatory agencies
• Oversite of document control systems and programs, ensure compliance and oversite of all QMS
• Provide guidance for GMP quality and support production operations.
• Anderson QA Supervisor would oversee activities for Finished Packaged Product and Packaging Component Inspection/Release activities.
• DDR QA supervisor would oversee activities for Finished Product (Bulk) in addition to FGs.

General Responsibilities

• Other duties as assigned.
• 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.

The Candidate

Education, Experience, and Licenses:

• Bachelor's Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology, and/or Biology
• Professional quality discipline certifications (CQE, CQA, CQM or RAB) 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.
• Professional Quality discipline certifications (CQMOE, CQE, CQA, RAC,) desired

Knowledge, Skills, and Abilities

• Excellent communication and interpersonal skills.
• Strong negotiation and problem-solving abilities.
• Proficiency in CRM software and Microsoft Office suite.
• Attention to detail and organizational skills.
• Comprehensive understanding of account management principles and practices.
• Familiarity with the retail industry and knowledge of key players and market trends.
• Ability to build and maintain strong relationships with clients.
• Effective time management and prioritization skills.
• Adaptability to changing priorities and client needs.
• Analytical mindset for data-driven decision-making.
• Excellent verbal and written communications and presentations skills, including effectiveness in conducting or participating in meetings, speaking before audiences, or providing training.
• Strong knowledge of FDA Quality Systems regulatory requirements and of standards quality assurance practices for manufacturing operations such as 21 CFR 111, 110, 117, 210, 211, ISO9001

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.