QC Associate
Responsible for managing and executing QC activities in support of product(s) production, release, and stability.
Ensures GMP activities are conducted in accordance with applicable SOPs, compendia, approved methods, and in accordance with company's and regulatory agencies' policies and procedures
Key Duties and Accountabilities
· Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.)
· Perform raw data review of third-party release and stability testing data
· Perform trending for release, and stability using applicable software (JMP, iStability, Graphpad, etc).
· Draft and review QC documentation including Stability Protocols and Reports, SOP's, Material specifications, CoA templates and other quality documents.
· In collaboration with Analytical Development, support method qualification, fit for use, validation and method transfer activities
· Support reference standard program
· Draft and execute quality systems (e.g., OOS/OOT, Deviations, Change Controls and CAPA's)
· Additional responsibilities and ad hoc projects as required
Qualifications
· BS with 5 years+ industry experience required
· 3+ years of quality control related experience
· Experience working in QC lab environment with knowledge of international and national regulations and guidelines related to product testing, familiarity with ICH analytical and stability requirements
· Experience with EDMS systems (Veeva, Mastercontrol, ZenQMS, etc) and LIMS (Labware, Labvantage, etc) a plus
· Excellent communication skills and ability to build key networks and business relationships across all levels of the business
· Experience in method transfer, validation, qualification a plus
· Lab experience in release and stability testing a plus
· Experience Drafting, Reviewing and performing data verification of regulatory filing sections
Please apply if interested or reach out to me directly at hanhunter @actalentservices.com!
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 ****** (%20******) for other accommodation options.