Quality Assurance Manager
Principle Job Function:
Conduct Quality Assurance audits of QPSI production facilities assuring company standards are maintained and project integrity is preserved. Consult with QPSI management to resolve quality, production, and efficiency problems. Function as an information source to customers to various company departments when special and critical quality issues occur. Function in conjunction with the Corporate QA Director on special department projects. Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial and packaging processes, materials, and projects. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. The individual appointed to this position must comply with the applicable QPSI procedures/work instructions, and customer requirements. The principle responsibility of every employee is to aid in the production of superior quality products.
The Senior QA Manager reports to the VP of Quality or designee and is responsible for managing the Site Quality department. This individual is responsible for the overall direction, coordination, evaluation, and compliance of the site's quality unit. Also, indirectly supervises production and maintenance personnel.
Principle Responsibilities/Essential Job Functions:
- Confirm that plant audit procedures are properly carried out and assigned work schedules are maintained.
- Determine overall plant project quality by conducting and evaluating various product tests and tests related to components and packaging.
- Resolve major quality problems at QPSI production facilities, warehouses, and market areas as required.
- Evaluate and take corrective action when necessary with regard to product date coding and trade age management at all levels of product movement.
- Educate and instruct plant personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices. Confirm these procedures are being maintained.
- Consult with plant management and personnel on better operational procedures to improve overall efficiency and project yields.
- Discuss plant evaluation with plant management, make appropriate recommendations and set timetable for improvement and corrections.
- Function as an information source for customers and other QPSI departments when critical quality issues arise.
- Prepare plant evaluation reports and submit them to Corporate QA Director on a monthly basis.
- Assist in development of special department projects and work in conjunction with Corporate QA Director.
- Accept responsibility of training and preparing new employees for this position on a daily basis.
- Develop, maintain, and conduct a review of internal quality systems every quarter, or as required.
- Administrative operation of the Preventative/Correction Action System as needed.
- Support of customer and agency audits.
- Qualification of personnel performing special processes as required by Standard Operation Procedures.
- Quality Assurance input within the approved supplier program.
- Ensuring that documentation and design controls are appropriate for organization.
- At least a Bachelor's degree, in a related field, or equivalent.
- 4-5 years' experience in Quality Assurance packaging / pharmaceutical field.
- Demonstrated track-record of accomplishments as a Quality Assurance Manager and with satisfying customers in packaging-driven companies.
- Ability to perform as a manager of job responsibilities.
- Experience with FDA and International Quality System rules and regulations, including planning and implementation.
- Excellent oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
- Ability to implement, promote and execute LEAN principles
- Ability to take initiative, maintains confidentiality, meet deadlines, and work in a team environment essential.
- PC-based computing experience (Word, Excel, PowerPoint, Access). ERP experience preferred.
- IS0 13485 & CFR PART 820 experience preferred
Quality Assurance record retention on a daily basis.
- Performing internal audits once a quarter, or as required.
- Administering document control on a daily basis.
- Addressing non-conformities from previous and current internal and external audits.
- Initiates or suggests plans to motivate workers to achieve work goals.
- Confers with workers' representative and Human Resources to resolve grievances.
- Interfaces with other departments and the internal trainer to develop and implement training programs.
- Authority for acceptance/rejection, including release of goods.
- Other duties as assigned.
Design, manufacturing, packaging, metrics reporting, and distribution in a single source, that's QPSI, the leader in contract packaging and supply chain solutions. With 36 years of experience satisfying the world's best pharmaceutical, healthcare, beauty, and consumer goods companies, we know how to get the most out of each step in the chain, from the first raw idea to the final product delivered to your customer.
QPSI knows your business. You want the best in supply chain discipline, innovation flexibility, customer service, and quality.
Supply chain discipline is in our DNA. No company today offers the level of KPI tracking and metrics reporting we do. Efficiency isn't just about streamlining the process; it's the best way to save you money.
Wed, 13 Sep 2017 11:54:11 PDT