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Description:
• Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.
• Perform document change control activities as needed.
• Perform and lead in investigations, NCMRs and Complaints.
• Track and monitor CAPAs.
• Perform training as needed.
• Support Distribution activities.
• Collect quality metrics.
• Support the Quality Operations Director with internal, supplier, regulatory and customer audits.
• Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor.
• Perform QC inspection or release of incoming GMP materials according to appropriate material specifications.
• Ensure department and company goals are met.
• May perform other department tasks.
Skills:
CAPA, GMP, NCMR, QA, QC, inspection
Additional Skills & Qualifications:
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
High School Diploma and/or 3-5 years related experience and/or training.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.
Ability to read various types of standard items addressed to general readers.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
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.
