Overview
Senior Specialist, Quality LIMS Administration Jobs in Chestnut Ridge, NY at Strides Pharma Inc
The Quality Technician supports new product/process development and manufacturing through the application of quality engineering techniques. This person will handle multiple projects and tasks throughout product development, product launch and manufacturing. Additionally, this individual will ensure that product meets quality standards consistent with customer and other regulatory requirements. The Quality Associate will represent the organization and interface with the customer on a regular basis. This role also supports plant activities in customer issues, supplier issues, and initiate corrective actions with an emphasis on process improvement.
Essential Duties and Responsibilities Include the following. Other duties may be assigned
Provide support in adhering to the quality management systems.
Creating and maintaining company documentation, such as quality documents, procedures and work instructions
Support Quality team in the APQP process for assigned projects / parts with a cross functional group to review; contracts, drawings, process routings, purchase orders, work instructions and various related production and development plans to achieve all customer quality requirements.
Determines the metrics/product characteristics that will be inspected with assistance from Quality Engineer/s
Determines the methods/devices that will be used for inspection with assistance from Quality Engineer/s
Collaborates with Manufacturing Engineer/s to assess the critical product characteristics that will be measured
Applies statistical process control (SPC) tools and methods as required
Assists qualification of new products / launch activities
Prepares appropriate documentation for product inspection, sample submissions (PPAP, FAI, FMEAs, Control Plans, Check Sheets, Quality Alerts, etc.)
Conducts/coordinates measurement evaluations and/or tests (FAI, Gage R&R, MSA)
Lead and participate in Corrective / Preventive Action teams to resolve customer, supplier and production concerns
Work with appropriate representatives to eliminate defects using tools such as root cause and corrective actions, lean techniques, A3s, counter measures, six sigma, poka-yoke and/or error proofing
Maintains a working knowledge of government, customer and industry standards and specifications
Communicate significant issues identified during quality activities and provide recommended process improvements to team and management
Participate as Material Review Board member to review and establish a timely disposition of Non-Conforming Material and ensure controls are in place to verify any rework performed.
Ensures that containment activities take place when discrepancies are identified.
Participate in audits of the Core Processes, implements Corrective Actions and recommends process improvements.
Support and instruct inspectors as well as create work instructions.
Trains associates on key characteristics of product to improve awareness of product quality
Participate in & initiate continual improvement activities
Complete CDR submissions/uploads and create Certificate of Conformance certs for product.
Perform quality related activities for ECN/PCR assigned.
Competencies
To perform the job successfully, an individual will need to perform the following competencies.
Quantity of Work
The quantity of work produced and the promptness with which it is completed.
Quality of Work
The ability displayed and accuracy of work produced, meeting company standards, and requiring little to no rework.
Judgement/Knowledge of Job
Knowledge of job, techniques, skills, equipment, procedures, materials, etc.
Attendance/Dependability
Punctuality and attendance.
Teamwork/ Attitude
Willingness and cooperativeness with co-workers and supervisors; ability to accept constructive criticism.
Initiative/Independence
The degree to which an employee searches out new tasks and expands their ability to perform assigned tasks without direct supervision.
Adherence to Policy
Follow quality environmental policies and have knowledge of AS9100 and IS14001.
Adherence to Safety
Follow safety procedures, security protocol, and wear proper PPE.
Education and/or Experience
Required High School diploma or equivalent general education degree (GED) and three five years related experience and/or training; or equivalent combination of education and experience.
Preferred associate degree in quality / bachelor’s degree in quality, mechanical, chemical, or industrial engineering or related experience and/or training.
Additional education and/or experience includes: skilled in problem solving and analysis, knowledgeable in the use and application of statistical process control, capable of reading and interpreting drawings, able to use and understand GD&T (Geometric Dimensioning and Tolerancing), ability to use all handheld and surface plate measurement devices, computer skills (including MS Office suite of products)
Reasoning Ability
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee may occasionally lift and/or move up to 50 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Title: Senior Specialist, Quality LIMS Administration
Company: Strides Pharma Inc
Location: Chestnut Ridge, NY
