Job Title: Quality Assurance Specialist

Job Description

As a Quality Assurance Specialist, you will be responsible for reviewing executed batch records and related documentation for manufacturing activities to ensure compliance with good documentation practices (GDP), product specifications, process parameters, and regulatory requirements. You will communicate effectively with cross-functional departments to ensure timely delivery of corrections, QA review, and disposition responsibilities. Additionally, you will compile and review all applicable documentation for batch review and release, oversee the status of batches to ensure QA batch disposition deadlines are met, and review analytical reports to ensure products, materials, components, and intermediates meet company standards and regulatory requirements.

Responsibilities

• Review executed batch records and related documentation for manufacturing activities in accordance with GDP, product specifications, process parameters, and regulatory requirements.
• Communicate effectively with cross-functional departments to ensure timely delivery of corrections, QA review, and disposition responsibilities.
• Compile and review all applicable documentation for batch review and release, and oversee the status of batches to ensure all QA batch disposition deadlines are met.
• Review analytical reports to ensure products, materials, components, and intermediates meet company standards and regulatory requirements.
• Review all test results generated in support of testing raw materials, in-process, finished products, and stability samples, including assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to in-house monographs and USP and other compendia in a regulated laboratory environment.
• Review environmental monitoring data, microbiology, and cleaning testing results.
• Review quality events, incidents, and deviations related to manufacturing processes and laboratory testing, including OOS, OOT, and OOE investigations.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.
• Provide required support during regulatory and internal audits.
• Keep track of data and records review indicators for internal quality metrics and annual product review.
• Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, and create and revise relevant documentation.

Essential Skills

• Bachelor’s degree in Life Sciences discipline.
• 4 years’ experience within the pharmaceutical, biologic, medical device, or regulated industry.
• 2 years’ experience in a Quality Assurance/Quality Control or Manufacturing function.
• 1 year batch record and analytical data review experience required.

Additional Skills & Qualifications

• Previous experience using analytical instrumentation, software, and tests performed in the lab, including: HPLC, GC, Dissolution, Raw Materials, etc. is preferred.
• Understanding of SOPs, STPs, USP/NF, GLP, ALCOA, and data integrity procedures, guidelines, and requirements.

Work Environment

Lab environment; FDA and GMP regulated. Clean room. Available shifts: 2nd shift (2pm - 10pm) and 3rd shift (10pm - 6am).

Pay and Benefits

The pay range for this position is $20.00 - $24.00/hr.

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 Coral Springs,FL.

Application Deadline

This position is anticipated to close on Apr 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 for other accommodation options.

Salary : $20 - $24