QA Support Manager

ESSENTIAL ACCOUNTABILITIES: • Leads and manages the performance and development of a team of 6 to 8 associates.
• Participates in the organizations current business communication tool and maintains Quality department metrics, including tracking and trending plant Quality metrics.
• Collaborates with departmental teams to ensure product safety and product quality.
• Tracks and trends plant Quality metrics.
• Coordinates and participates in Quality Management Reviews.
• Analyzes quality, process, and test data for finished goods or suppliers.
• Develops quality improvement plans which support strategic objectives for finished goods or suppliers.
• Develops, implements, and evaluates QMS processes.
• May coordinate cGMP, Regulatory, and HACCP training for the facility.
• Tracks, controls, and determines disposition of non-conforming raw material, in-process, and finished product.
• Investigates customer and consumer feedback.
• Tracks and trends site customer and consumer complaints or supplier complaints.
• Participates in regulatory, customer, and third-party audits and visits.
• May coordinates Internal or Supplier Audit Program.
• Coordinates internal and external Corrective and Preventive Action (CAPA) program related to finished goods or suppliers.
• Ensures QMS Document System is reflective of actual practices.
Creates, reviews and edits documents as needed to ensure compliance to FDA regulations and guidance.
• May provide technical support in the Lab as needed.
• Proficiency in JD Edwards, Agile and Infinity with the ability to complete QA functions in both systems.
• Completes Global QA projects and addresses Global QA inquiries.
• Exercises decision-making with good judgment.
Shows initiative in gaining/maintaining skills, abilities and knowledge required to perform effectively.
• Demonstrate commitment to Rockline’s RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
• Associates have a direct and important role in ensuring that all work is performed in a safe manner.
Effectiveness in carrying out this responsibility is part of each associate’s essential accountabilities.
• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested This position is designated as a Safety-Sensitive (A safety-sensitive position is one in which the associate’s inability or impaired ability to perform their job-related tasks could result in a direct threat to the associate’s safety or the safety of others).
QUALIFICATION REQUIREMENTS: (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
) • Bachelor of Science in related Science or Engineering field (Biology, Chemistry, Chemical or Quality Engineering).
• Minimum of 3 years experience in decision making related to critical quality management processes and systems plus 3 years experience supervising a Quality Assurance staff in an industrial or manufacturing setting.
• Experience in driving continuous improvements in the Quality Management System and experience in the CAPA process.
• Experience in leading Quality System internal or external audits.
Experience in Sanitation programs in a manufacturing setting.
• American Society of Quality (ASQ) technical certification (Quality Auditor, Six Sigma, Quality Engineer, Quality Manager) preferred.
• Must be proficient in Microsoft Office programs, specifically Word, Excel, Power point and Outlook.
Understanding of Statistical Process Control desired.
PHYSICAL AND MENTAL REQUIREMENTS: (The physical demands described here are representatives of those that must be met by an associate to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions) • Must be able to communicate face-to-face and over the phone • Occasional lifting up to 35 lbs.
• Frequent standing/walking.
Occasional sitting, bending, twisting, kneeling, climbing, pushing/pulling and reaching.
• Repetitive hand and foot movement.
• Work environment includes occasional noise >85db, hot and cold temperatures.
• Requires ability to read, write, calculate and analyze.
• Requires good visual acuity with depth perception and color vision.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
41 CFR 60-1.
35(c)