Intermediate Ii Qa Tester Jobs

QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).

Performs a variety of activities to ensure compliance with applicable regulatory requirements.

Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations

Demonstrates audit and investigation skills, and report writing skills.

Demonstrates strong verbal, technical writing and interpersonal skills.

Prior experience in pharmaceutical industry is beneficial.

Execute test responsibilities with minimal supervision.

Experience in developing tests in Cucumber.

5+ years of working experience is required.

Assist the senior QA member or Lead in identifying test scope, test risks, and test methodology.

Create and maintain test documentation.

Interface and communicate with internal teams and external support groups.

Previous experience with software quality tools (test case management, project planning, automation)

Required Knowledge, Skills and Abilities

Position Responsibilities & Specific Accountabilities

Participate in the review of requirements

Acts as a resource to more junior staff and provides them with orientation/knowledge on specific product areas

Must have excellent written and verbal communication skills

Other duties that management may from time to time assign.

Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.

Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)

Verification of functionality of all the equipment and associated controls during the batch run

Disposition of rejected material and returned drug products as per SOP

Performs environmental monitoring in accordance with established schedule (where applicable)

Makes decisions based on regulatory requirements and communicates those decisions to management.

Develops and manages the facility’s Quality Management System to ensure:

Lead preparations and presentation of Annual Management Review.

Exercises decision-making with good judgment. Shows initiative in gaining/maintaining skills, abilities

Maintain Social compliance and sustainability certifications.

Oversight of quality requirements for IQ/OQ/PQ of new equipment, process and cleaning validations.

Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.

Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.

Demonstrated experience in regulatory inspection activities.

Experience working successfully both independently and in a team environment.

Strong verbal and written communication skills.

Root cause analysis experience preferred.

Project Management: Familiarity with JIRA (or relevant software) is preferred, as it helps manage and organize project tasks effectively.

Tuition reimbursement and education benefits

Review requirements and technical design documents to create detailed, comprehensive, and well-structured test plans and test cases.

Bachelor's degree in Computer Science or Information Technology or equivalent years of experience.

Comprehensive medical & dental including prescription drug benefits and 100% preventive care

Discounts, free food, swag and… honestly, too many good benefits to name

Experience tasking remote testers and providing feedback on effectiveness.

Experience tasking remote testers and providing feedback on effectiveness

3+ years of experience in Software Quality Assurance

1+ years of experience testing service features or client applications

Experience designing and executing test plans at both the system and service layer

Experience managing components of a defect database

Take the annual Automated Optical Inspection re-certification of operator and pass the subsequent test, in addition to manufacturing certifications.

Understand, recognize and execute Jabil production requirements, rules, policies and procedures.

Understand and analyze the fault data output from AOI and act accordingly for rework, using appropriate Jabil software packages.

Escalate to the appropriate technician in the event of a borderline fault.

Understand and use the Down Time Tracking and T.E.D. time ticket software.

Work as a team member to achieve Test/Manufacturing department’s process yield goals.

Experience using Confluence Team Collaboration or knowledge of how to work with a wiki Experience with SDLC (software development life cycle)

Works with QA Manager to create test schedules and plan resources accordingly

Authors Knowledge Base articles as required

2+ years of experience in a quality assurance and/or development environment

Experience installing/configuring Mac, PC, Linux, iOS, Android systems and applications

Knowledge of networking protocols and audio over Ethernet standards

Familiarity with SAP, MES (electronic batch records), TrackWise (quality event management), or equivalent systems.

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Responsibilities will include but not limited to tasks mentioned above.

Minimum 2 years of relevant work experience.

Quality Assurance experience within pharmaceutical or a related industry.

Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines.

May consult with Quality Management regarding key decisions which need to be made within his/her defined area of responsibility.

Please see "Education" section above for minimum requirements.

Directly supervise employees engaged in various Quality related tasks as well as assign job duties.

Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.

Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

Excellent communication skills (written and verbal).

Experience with test case management software/testing automation support

Experience gathering, analyzing, and documenting functional requirements

Work with cross functional testing teams to create and execute automated, regression test cases based on requirements

Create the appropriate test plans based on requirements and the development process

8+ years of Testing experience

Hands on experience with Behavior Driven Development using Cucumber which integrated feature files, Step Definition and Runner classes in Gherkin language.