Quality Systems Associate

7 days ago


Harleysville, United States Actalent Full time

Job Title: Quality Systems AssociateJob Description

Ensure compliance to cGMP standards in the Manufacturing and Packaging areas. All production control records must be compiled, complete, and accurate. All Laboratory Services release testing must show satisfactory conformance to bulk and finished product specifications. Execute or coordinate the resolution to excursions identified during the batch review process. Issue and perform review of logbooks and notebooks. Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories. Adherence to customer release requirements. Update paper and electronic records. File and archive documentation.

Hard Skills

+ Ensure company-wide adherence to cGMP standards

+ Standard Operating Procedures

+ Customer specifications

+ Compliance to cGMP standards in Manufacturing and Packaging

+ Accurate production control records

+ Laboratory Services release testing

+ Resolution of batch review process excursions

+ Review of logbooks and notebooks

+ Documentation management

Job Type

This is a Contract-to-Hire position with a duration of 5 Month(s).

Work Site

This is a fully on-site position in Mainland, Pennsylvania.

Work Environment

Will be split between office environment, packaging, and lab. Team of 6, currently 2 on first shift (looking to add a 3rd), and 3 on second shift. One position on 2nd shift: Hours: 2nd shift 3pm-12am with 1-hour unpaid lunch. One position Thursday-Monday, can be either 1st shift (8am-5pm) or 2nd shift (3pm-12am) with 1-hour unpaid lunch.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.



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