QA Specialist II

Company Description

Softpath System has a reputation as a unique firm in a fast-paced information technology marketplace. Softpath helps customers to consistently and cost-effectively plan, execute and deliver high-quality services and results. Our consultants are experienced professionals who build long-term, trusted relationships and bring a high level of innovation, integrity, experience and value to client work. In addition, Softpath as a systems integrator has strong partnerships with best-in-class technology vendors, enabling Softpath to remain objective while working with customers to determine the best hardware, software and services to meet their business requirements. 

Softpath's excellent customer care delivers the depth and breadth of services resulting in significant repeat business with customers. Softpath helps our customers make optimal use of technology today while planning for the future. More than 100 customers - and many of the Fortune 500, Global 1000 rely on Softpath's expertise to maximize their technology investment. 

Softpath was incorporated in 1999, and has grown to over 450 employees worldwide. Corporate Headquarters are in Atlanta, Georgia with Regional Offices in the Raleigh, NC, Omaha, NE and Hyderabad, India. Our customers are diverse and include companies of all sizes large, middle market and start-up.

Job Description

Greetings    

This is Umar from Softpath System LLC. Softpath is a preferred nationwide staffing vendor to Fortune 500 companies in the US. We have an immediate opportunity with one of our clients. Please find the job description below and if you are interested, please applyfor this position. You can also reach me at

Job Details:

Title: QA Specialist II

Location: Abbott Park, IL,

Duration: 12 Months   

Shift Days: Monday – Friday

******** The position does not provide Sponsorship; must possess work authorization in the U.S. - US Citizens, Green card ********

Job Description:

Required:

• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). 

• BS degree or 3-7 years equivalent experience 

• Ideally a bachelor's degree in a science or closely related discipline or equivalent relevant experience

MQA Quality Technician 

Primary Job Function: 

• Provide technical input to facilitate CAPA investigations. Completes assigned daily activities; workload; scheduling; and constraints independently. Provides technical expertise to complex projects / product and investigations as required. Strives to become the technical expert within work area.

Core Job Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.

• CAPA - Maintain knowledge of the CAPA System.

• Communications - Communicate and collaborate effectively within team and with internal stakeholders as guided by manager. Participates in Cross Functional Teams.

• Documentation - Maintain; review and update relevant documents and records.

• Basic Requirements - Provides input into the annual departmental budget.

• Manage Product and Process Improvements - Under general supervision; works on process improvement activities within own work area. Monitor performance of manufacturing processes and implement required improvement activities. Suggests and implements approved process improvements within own work area that fosters a culture of continuous improvement. Works independently on area assignments for multiple key processes and projects. Proactively seeks improvement within Quality Technical work area.

• Management of Computer Systems - Maintain and update relevant computer applications.

• Quality/Compliance -Support manufacturing and testing operations as required; adhering to Good Manufacturing Practices and Good Laboratory Practices. Demonstrate strong knowledge of all technical processes/procedures within area of responsibility. Keep abreast of the standards that regulate our industry. Participate and take all trainings and reviews as required on the Electronic Training Management System -ETMS. Conduct business in a manner that will protect human health; safety and the environment by complying with all applicable EHS laws; as well at the Abbott Global and Technical standards. Comply with Abbott Quality System (QS) requirements.

• Share Quality Knowledge - Share quality knowledge; liaising with colleagues within team.

• Training - Train others in multiple key processes within work area. Assists with the collation of information requested during audits. Undertake all trainings and reviews are required on the Electronic Training Management System -ETMS. Utilize quality experience to train others.

• Testing (Micro LF; SL) DF - No testing in QA:

• Complete Quality testing as appropriate for products per procedures and review all data to determine conformance with specifications.

• Ensure that plant Environmental Monitoring program if applicable is executed per procedural requirements and schedule; and that environmental data is tracked and trended . Provide information for tracking and trending of data as required.

• Incoming Quality Assurance:

• Incoming Inspection - Conduct Inspections of incoming items per standard requirements.

• Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.

• Change Control Technical Specialist Specific: Initiates site Change Plan and Document Change Request activities for changes identified through:

• Product / Process improvement

• Transfer activities

• Identified compliance issues. Co-ordinate and manage Change Plan and Document Change Requests through to closure; including tracking of identified deliverables and action items. Work in conjunction with relevant Document/ Process owners to identify and organize CFTs. Complete required document authoring and approval tasks as required for QSR and DMR documents. Keep up to date with all training requirements via Electronic Training Management System (ETMS) and other systems as required. Attends process community meetings.

• Ownership - Is recognized as an lead technician for one or two key processes within work area.

• Position Accountability / Scope:

• Troubleshoot issues and applies problem solving skills and take appropriate actions to resolve.

• Perform activities as assigned by Team leader / Manager. Take appropriate actions to resolve and communicates resolution to area Team leader / Manager. Support relevant activities. Undertake developmental opportunities to become the lead in Testing.

Qualifications

Bachelor's degree in a science or closely related discipline or equivalent relevant experience

Additional Information

All your information will be kept confidential according to EEO guidelines.