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Quality Inspector
Westminster, MA
Job Description
Description
Acara Solutions is looking to hire a Quality Inspector for our client in Westminster, MA.
Hours: Mon-Fri 7:30am-4pm
Pay: $22/hour
MAJOR JOB DUTIES AND RESPONSIBILITIES:
* Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
* Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented VWR Solon procedures and GMP requirements.
* Ensures customer requirements are met.
* Verifies adherence to policies, procedures, and work instructions.
* Ensures documentation and physical product segregation and containment of non-conforming material identified during the production process.
* Reviews production documentation for accuracy, completeness, and GDP compliance.
* Assists in correcting order issues and ensures actions that are taken are appropriate.
* Communicates issues / concerns to area owner and direct manager.
* Ensures that the area is in a state of audit readiness at all times.
* Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components, and documentation.
* Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required.
* Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures. * Documents non-conformances following applicable VWR Solon procedures and work instructions.
* Documents and trends any quality production issues discovered during the course of inspection duties.
* Ensures cleanliness of work areas during the inspection processes.
* Utilizes problem solving tools such as 5M+E, 5 Whys, or other root cause analysis tools / methods to identify and permanently resolve issues.
* Adheres to VWR Solons QMS and VWR Policies, where applicable.
* Walks the floor to observe, train, and facilitate / support change.
* Performs other duties as assigned.
Job Requirements
QUALIFICATIONS
* High School completion or equivalent (GED) and a minimum of 3 years related experience and/or training in a regulated industry is required; OR * Bachelors degree is required
* Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry is
PREFERRED KNOWLEDGE SKILLS AND ABILITIES
* Must be able to balance multiple tasks and prioritize efficiently
* Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard is preferred
* Demonstrated experience or knowledge in conducting root cause analysis as it relates to nonconforming material investigations
* Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
* Good communication skills
ENVIRONMENTAL WORKING CONDITIONS/PHYSICAL EFFORT
Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
3+ years
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