Description:

　　Performs routine and non-routine testing with expert proficiency and general QC laboratory work for release of Direct Raw Materials to support clinical development and/or commercial products in a GMP testing environment.

　　Principal Responsibilities:

　　• Applying the principles of good manufacturing practices (GMP) on a daily basis

　　• Performing sample testing for raw material release testing

　　• Analyzing and compiling data and preparation of reports

　　• Reviewing assays/data for compliance to specifications and reports abnormalities

　　• May require lifting/moving heavy objects

　　• Supporting/managing the daily activities of the lab (responding to RUSH requests, starting raw material batches, assigning of assays)

　　• Support Release of raw material lots, CoA generation and approval

　　• Creating and revising standard operating procedures (SOP’s, Specifications, and Test Methods) and other documents as needed

　　• Identifying and leading continuous improvement projects

　　• Supporting special projects for analytical problem solving

　　• Participating in the qualification and validation of test methods

　　• Troubleshooting laboratory or system anomalies

　　• Authoring and owning deviations, CAPAs and Change Controls

　　• Method or system development and/or optimization.

　　• Training other personnel

　　• Serving as SME for Test Methods or other areas of expertise

　　• Providing oversight for programs, specific to job function

　　• Representing QC in cross-functional teams

　　• Weekend, Holiday, overtime, and off-hour work may be required as needed to support manufacturing.

　　Additional Skills & Qualifications:

　　• Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience)

　　• Broad experience with Microsoft Office products

　　• Be highly organized with an attention to detail

　　• Strong data interpretation/analytical skills

　　• Strong troubleshooting skills

　　• Strong knowledge of GMP compliance

　　• Strong technical writing and communication skills

　　• Experienced in lab equipment (pH meters, balances, pipettes, HPLC's/plate readers, automated titrators, spectrophotometric instrumentation, etc.)

　　• Experience authoring or revising Standard Operating Procedures

　　• Familiarity with Change Control

　　• Participation in Laboratory Investigations

　　• Ability to keep order of multiple projects/tasks

　　• 4+ years of experience working in a GMP laboratory

　　• Participation in Laboratory or Out of Specification Investigations

　　• Experience or working knowledge of compendial methods/monographs as it applies to raw material testing*

　　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.