Overview:

This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Responsibilities Include the Following:

Provide Quality oversight to ensure that operations products are manufactured tested stored and distributed according to current applicable regulations. Ensure that facilities equipment materials organization processes procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes procedures documents and records. Review logbooks batch records attachments work orders and other GMP documentation. Ensure that deviations from established procedures are documented per procedures. Ensure that production records and testing results are complete accurate and documented according to written procedures and cGMP requirements. Alert management of quality compliance supply and safety risks. Complete required assigned training to permit execution of required tasks. Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.

Preferred Qualifications:

Bachelors degree and 2 years of Quality or Manufacturing work experience Experience working in a cGMP environment Experience with decision making Experience with analytical testing and/or general compendia testing Experience working with batch records and other GMP documentation Knowledge of data integrity requirements Proficient in Microsoft Office e.g. Outlook Word Excel PowerPoint MS Teams Experience collaborating within and across functional areas and demonstrated customer service focus Excellent written and verbal communication skills Ability to prioritize and navigate ambiguity with minimal oversight in a fast-paced environment

Pay and Benefits

The pay range for this position is $28.00 - $33.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in West Greenwich,RI.

Application Deadline

This position will be accepting applications until Jan 20, 2025.

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.