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Quality Assurance Manager
$94k-117k (estimate)
Full Time | Religious Organizations
4 Days Ago
Berkshire is Hiring a Quality Assurance Manager Near Whitsett, NC
Key Job Functions
- Plan, implement, communicate, and maintain the effectiveness of quality programs in compliance with applicable ISO, cGMP, and industry standards.
- Set quality assurance objectives for the review and approval of Top Management and oversee activities to ensure they are achieved
- Fulfill the ISO Management Liaison role with ISO registrar to ensure relevant registrations are maintained.
- Schedule, facilitate, and document ISO Management reviews for the organization on an agreed upon frequency.
- Manage the internal ISO audit process, communicate audit results, and oversee the timely implementation of any necessary corrective actions.
- Manage the ISO document control process including review and approval of SOPs, supplier specifications, and finished product specifications.
- Participate in new product development activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing.
- Work with Quality team and Operations to design and implement an effective CAPA process.
- Work with Procurement to establish and maintain the supplier approval / supplier audit process.
- Manage the sterile validation process for manufactured products in compliance with ANSI/AAMI guidelines.
- Develop, edit, review, and approve validation protocols and reports.
- Understand global regulations affecting key product lines and coordinate with other functional areas and outside consultants to as needed to ensure compliance.
- Manage the company’s change control process.
- Work with Marketing to ensure customer facing product technical information is reviewed regularly and updated as required.
- Review results of product testing and update internal and supplier specifications as needed.
- Work with the Quality and Operations teams to establish targets for quality improvement efforts and track results of activities.
- Design and implement quality training programs in conjunction with managers.
- Demonstrate integrity and professionalism
- Demonstrate a positive attitude in the face of challenges
- Maintain a professional demeanor both internally and externally with vendors, customers, and suppliers
- Maintain a high attention to detail to ensure compliance to standards
- Ability to work independently as well as positively and proactively in a team
- Reacts with an appropriate sense of urgency to production and customer needs
- Ability to communicate and work well with all levels of the organization
- Bachelor’s degree or higher from an accredited college or university in a science or engineering related field.
- Ten years of experience in a manufacturing environment including five years in a quality management role.
- Solid understanding of sterility validation and guidelines and processes.
- Strong knowledge of FDA, cGMP, and ISO requirements.
- Excellent written communication skills including devising procedures, developing work instructions, and writing reports for internal and external use.
- Ability to effectively prepare and present information in one-on-one and group situations.
- Ability to use judgement in the analysis of facts and circumstances surrounding individual problems and transactions and in the determination of action to be taken within the limits of standard or accepted practice
- Excellent computer aptitude and knowledge of Microsoft Office (Word, Excel, PowerPoint) and ERP system software
- Textile industry (knitting, finishing, yarns), Knits and Nonwovens experience
- Pharmaceutical or medical device industry experience a plus
- Lean /Six Sigma working knowledge and experience
- Previous experience with ISO 9001, ISO 14001, and ISO 17025 systems in a manufacturing environment
- Previous experience with LIMS systems
- Previous experience with EPA or BPR regulations for disinfectant products
- Hands to finger, feel, and handle testing equipment and product; operate computer
- Frequent standing, walking, sitting, reaching with hands and arms
- Occasional lifting and moving of up to 25lbs
- Occasional climbing, balancing, stooping, crouching, crawling, smelling
- Close, peripheral and depth perception vision
- Work performed in normal office environment
Job Summary
JOB TYPE
Full Time
INDUSTRY
Religious Organizations
SALARY
$94k-117k (estimate)
POST DATE
05/01/2024
EXPIRATION DATE
06/30/2024
HEADQUARTERS
BEAVER FALLS, PA
SIZE
50 - 100
FOUNDED
2008
REVENUE
$10M - $50M
INDUSTRY
Religious Organizations
Related Companies
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The following is the career advancement route for Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Manager. You can explore the career advancement for a Quality Assurance Manager below and select your interested title to get hiring information.
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