Actalent Westbrook , ME 04092
Posted 3 days ago
Description:
Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities
Conduct product testing including testing to support complaint investigations and stability verification
Generate product testing results reports
Review production batch records DHR's for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Participate in the internal audit program
Write review and approve Standard Operating Procedures SOPs as necessary
May assist in supporting the Document Control program record retention areas and sample retention areas
May support returned instrument processing
Log returned instruments from the field.
Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing.
As necessary process instrument documentation for return to repair facility and pack instruments as required.
Other duties as assigned by supervisor
Qualifications
To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge skill and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to follow Good Manufacturing/Laboratory Practices GMP and GLP
Education and/or Experience
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
At least one year in quality assurance role in medical device industry is preferred.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Actalent