Scientist

Responsibilities

• Identify and recommend improvements to processes to maintain quality, cost-effectiveness, safety compliance, and other parameters.
• Perform timely release testing on all incoming raw materials needed for manufacturing and finished goods.
• Cook scheduling of all materials to meet company requirements.
• Ensure that assigned products meet quality requirements for the customer and the company.
• Draft written reports detailing results of testing analysis and approve the release of raw materials and finished goods.
• Proactively identify trends in laboratory analysis or functions and act to make improvements while communicating to management.
• Perform operations for CMO support as necessary.
• Operate and maintain laboratory equipment; identify problems when equipment fails and conduct or recommend repairs.
• Perform maintenance and calibration of all equipment as needed.
• Review and/or draft SOPs as needed to update to current procedures.
• Author and execute written protocols and IQOQs as needed.
• Cross-train to perform sample lab duties adequately and accurately.

Requirements

• Excellent organizational skills and attention to detail.
• Proven ability to meet deadlines with strong time management skills.
• Strong verbal and written communication skills to work with all levels of management and vendors.
• Strong analytical and problem-solving skills, including the ability to read and understand instructions and materials in English.
• Ability to function well in a high-paced and occasionally stressful environment.
• Thorough understanding of FDA and cGMP compliance regulations.
• Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, and related software.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, or Biology.
• Working knowledge of scientific instrumentation and techniques.
• Working knowledge of Regulatory, cGMP, and FDA regulations to ensure products and production units meet quality standards.
• Proficient computer knowledge, including basic spreadsheet functions and word processing.
• 2-4 years of audit experience, preferably in a pharmaceutical facility.
• 2-4 years of supervisory experience.
• Valid driver’s license and ability to operate a vehicle.

Skills

• Excellent organizational skills and attention to detail.
• Proven ability to meet deadlines with strong time management skills.
• Strong verbal and written communication skills to work with all levels of management and vendors.
• Strong analytical and problem-solving skills, including the ability to read and understand instructions and materials in English.
• Ability to function well in a high-paced and occasionally stressful environment.
• Thorough understanding of FDA and cGMP compliance regulations.
• Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, and related software.

Benefits

• Medical, dental & vision coverage.
• Critical Illness, Accident, and Hospital coverage.
• 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 coverage.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation or Sick Leave).

Pay and Schedule

• The pay range for this position is $25.00 - $30.00/hr.
• This is a Contract to Hire position based out of Omaha, NE.

About the Role

The role involves identifying and recommending improvements to processes to maintain quality, cost-effectiveness, safety compliance, and other parameters. It requires performing timely release testing on all incoming raw materials needed for manufacturing and finished goods, as well as coordinating scheduling of all materials to meet company requirements. The position ensures that assigned products meet quality requirements for the customer and the company. The scientist will draft written reports detailing results of testing analysis and approve the release of raw materials and finished goods. Additionally, the role involves proactively identifying trends in laboratory analysis or functions and acting to make improvements while communicating to management.

Work Environment

The work environment involves working around the lab and throughout the facility, assisting with audits and other FDA documents. The role may require working in a high-paced setting, ensuring adherence to safety and compliance standards.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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.