Overview
Manager, Test Automation (Hybrid) Acton, MA Jobs in Acton, MA at Insulet Corporation
;jnbjPOSITION DESCRIPTIONPosition Title: QA Investigation Specialist Department: Quality AssuranceReports To: Director, Quality Assurance Work Location: Decatur, IllinoisCompensation: $80,0000 – $90,000 FLSA Status: ExemptPosition Summary:Manages, implements and coordinates investigations program to assure that all excursions are adequately investigated for determination of root cause and that corrective and preventive actions are identified and implemented to prevent/reduce excursions in processes and procedures.Essential Duties & Responsibilities:Responsible for the assignment, tracking, and monitoring of all investigations, corrective and preventative actions (CAPA), effectiveness checks (EC) and customer complaints at the Decatur site. Work with cross-functional personnel to ensure that a comprehensive investigation is performed, and effective corrective and preventive actions are created to prevent future occurrences of a deviation. Responsible for providing guidance to the investigators to ensure that all Decatur site investigations comply with regulatory requirements. Responsible for coordinating priorities for the Investigators to ensure timely closure investigations, CAPAs, ECs and customer complaints. Quality review and evaluation of all investigations, CAPAs, ECs and customer complaints. Assist during regulatory inspections, customer audits and internal audits as required.Education and Experience:Bachelor’s degree required. Minimum of 4 -6 years experience in a Quality role relating to investigations, corrective and preventative actions (CAPA), effectiveness checks (EC) and customer complaints. Must have experience in performing cGMP related training.
Job Prerequisites: All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidance.
Physical Demands, Mental Requirements, and Work Environment:While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.Mental RequirementsAbility to write, read, and apply technical scientific writing, procedures, and quality policies. Ability to work independently in an efficient and detail-oriented manner. Ability to work on multiple projects and priorities in a concurrent manner. Ability to work in an independent manner, as well as a group environment. Ability to apply deductive reasoning and analytical thought to understand complicated issues. Ability to receive instructions and follow work rules and company policies. Ability to follow safety and security practices. Ability to meet deadlines and effectively deal with a high level of office stress. Ability to maintain confidentiality of work assignments and personnel issues.Safety Requirements:Safety glasses, close-toed shoes, and latex gloves are required in many areas within the facility.Disclaimer:The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.QA INVESTIGATION SPECIALISTPage 2 of 2
Job Type: Full-time
Pay: $80,000.00 – $90,000.00 per year
Benefits:
401(k)
401(k) matching
Health insurance
Life insurance
Schedule:
8 hour shift
Shift availability:
Day Shift (Preferred)
Ability to Commute:
Decatur, IL 62521 (Required)
Ability to Relocate:
Decatur, IL 62521: Relocate before starting work (Required)
Work Location: In person
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Title: Manager, Test Automation (Hybrid) Acton, MA
Company: Insulet Corporation
Location: Acton, MA
