at Actalent in Portland, Maine, United States
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
o Log returned instruments from the field.
o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
+ Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
+ 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.
+ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Hours: 7am-3pm Mon-Fri?
If interested in this job opportunity, please apply and reach out directly to Stephanie Lipari at slipari@ actalentservices.com.
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
Actalent is an equal opportunity employer.About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.