The Quality Assurance Manager develops, interprets, and implements quality policies, manages the quality systems, and facilitates regulatory compliance, customer and third party audits. Manages QA operations to support cGMP manufacturing, testing and releases of finished product under FDA regulations, applicable international regulations, GLP standards and internal procedures. Responsible for conducting investigations into product safety or cGMP-related issues, management of change control, product complaint process, SOP preparation/revisions, CAPA system and cGMP training programs.
1. Lead and manage all site quality assurance operations in order to assure the quality of raw materials from suppliers, work in process and finished product manufactured at the facility.
2. Serve as primary site contact for regulatory, customer or third party audits. Formulate responses to any findings from the audit and issue corrective actions where needed.
3. Develop and execute site QA operating budget and manage department efforts to control costs within approved levels.
4. Develop direct reports and work closely with them to ensure that a consistent approach is taken in evaluation of quality issues.
5. Collaborate with operations management team to develop projects to align with the strategic vision of the facility and support key performance indicators.
6. Administers the assigned budget(s) for which responsible, and provides status reports as scheduled or requested.
7. Develops and maintains good relations with community agencies, other employers, service clubs and educational institutions.
8. Reviews carefully all important or contractual paperwork completed within the department, including all required record keeping minimizing problems or potential liabilities. Continual attention to detail and internal training keeps the risk of problems or liability as low as possible.
9. Keeps immediate supervisor informed of important matters which must be handled at that level, with particular emphasis on critical incidents related to employee safety, security, union activity.
10. Shows initiative in gaining and maintaining the skills, abilities, and knowledge required to perform this position in at least a fully-qualified and satisfactory manner.
Education, Experience and Skills Required:
§ BS degree or higher in a scientific field. Strong background in chemistry and/or microbiology is preferred. ASQ Certifications preferred.
§ Seven to ten years progressively complex experience in Quality Assurance, including a minimum of three years supervising and managing staff.
§ Prior work experience in a leadership role in a GMP or FDA regulated manufacturing facility (cosmetics, drugs, devices or food)
§ Strong verbal, written, analytical and interpersonal skills.
§ Ability to organize and prioritize workload and to meet deadlines.
§ Demonstrate speed, consistency and accuracy in all tasks.
§ Interpersonal communication skills sufficient to work closely with others on a team to ensure successful collaborative completion of projects/tasks.
§ Maintain high level cognitive, interpretive and judgment skills.
Excellent Compensation and Benefits Package includes:
*Competitive Salary *Advancement Opportunities *Holiday and Vacation Pay
*Company matched 401(k) Plan *Health, Vision & Dental Insurance *Tuition Reimbursement
*Life, Accidental Death and Dismemberment Insurances
Please send resume and salary requirements to:
Rockline Industries is an Equal Opportunity Employer M/F/D/V
Please send your resume to the following email address: firstname.lastname@example.org
Rockline Industries, Inc - 16 months ago
Rockline Industries is a family owned corporation established in 1976.
Rockline is principally engaged in the manufacturing and marketing...