QA Aseptic Technician

Actalent

Description:

-Responsible for the mechanical setup, operation, control, monitoring and cleaning of various equipment to inspect & package sterile injectables while following Standard Operating Procedures (SOPs). Will be working in an Aseptically clean environment to minimize microbial contamination.

– Will be manufacturing and putting the pharmaceuticals together to send to their clients.

Autoclave / Sterile Instrument/ Glass/ and Vial Wash Machine Operation

To ensure that OPS services are compliant with the site’s quality standards, practices, procedures and documentation requirements and with site, local and federal safety requirements.

To provide OPS services in a timely manner to ensure to meet site and business goals.

To provide OPS services according to approved procedures.

To identify, investigate, participate in and when necessary to take ownership of compliance issues and deviations when discovered and to support the identification and implementation of corrective and preventive actions (CAPAs).

To work cooperatively with the Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities

To ensure that all SOPs, packaging labeling records, logbooks and other related documentation are completed according to GMP and Good Documentation Practices.

To participate in relevant meetings and additionally to report on/contribute to job/safety related matters as appropriate.

Observes safety and security procedures; responsible for meeting department safety objectives and to adhere to on-going safe operating procedures consistent with the job requirements.

To complete assigned trainings in a timely fashion to ensure that both personal and department training status remains current.

Skills:

GMP, Contract Manufacturing, inspection, quality assurance, Aseptic Technician, Aseptic, Sterile, Sterile Injectables, Injectables, Document control, Compliance, Quality control, Filling, Aseptic technique, kitting

Additional Skills & Qualifications:

Requires the ability to read, write, and perform basic math calculations (addition, subtraction, multiplication, and division).

Must comprehend and follow verbal and written instructions, such as cGMP’s, SOP’s, Batch Records, policies, procedures, etc.

Knowledge of current federal, local and international regulations regarding the production of drug substances and products.

Good understanding of cGMPs, industry and regulatory standards and guidelines.

Good understanding of federal and local regulations regarding health and safety within a manufacturing environment.

Proficiency with math, the metric system, weight and volume measures.

Strong ethical foundation and a sound compliance understanding.

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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