Job Title: Specialist Quality ControlJob Description

We are seeking a Specialist in Quality Control with 8-10 years of experience in managing GMP samples. The ideal candidate will be responsible for tasks associated with establishing routine procedures and defining business processes in support of the QC Sample Management group. This includes picking up samples in manufacturing, shipping/receiving GMP samples, and managing stability samples.

Responsibilities

• Assist with procurement activities for consumables and critical reagents for lab start-up.

• Support the startup and qualification/validation of the Sample Management and Stability Laboratories in a GMP environment.

• Assist with establishing the processes and procedures for sample handling and storage.

• Develop/Perform routine Sample Management laboratory procedures, including Sample Manufacturing Sweeps, aliquot cGMP samples, managing sample shipments, and Contract Testing Laboratory (CTL) Management.

• Maintain and operate specialized equipment as applicable.

• Initiate and/or implement changes in controlled documents.

• Support routine activities over the weekends and public holidays as required.

Essential Skills

• Sample Management lab experience.

• Familiarity with documenting tasks within LIMS.

• Experience in establishing processes and procedures for sample handling and storage.

• Proficiency in adhering to safety guidelines and cGMPs/CFRs, including maintaining training records, laboratory documentation, written procedures, building monitoring systems, and laboratory log books.

Additional Skills & Qualifications

• Doctorate degree OR Master degree and 3 years of experience.

• Bachelor degree and 5 years of experience.

• Associate degree and 10 years of experience.

• High school diploma/GED and 12 years of experience.

Work Environment

The work environment involves developing and performing Sample Management laboratory procedures such as Sample Manufacturing Sweeps, aliquot cGMP samples, managing sample shipments, and Contract Testing Laboratory (CTL) Management. The role requires maintaining and operating specialized equipment and supporting routine activities over the weekends and public holidays as needed. The candidate must comply with safety guidelines and cGMPs/CFRs, which includes maintaining training records, laboratory documentation, written procedures, building monitoring systems, and laboratory log books.

Pay and Benefits

The pay range for this position is $33.00 - $37.00

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 Holly Springs,NC.

Application Deadline

This position will be accepting applications until Jan 10, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.