Job Title: Quality Control Compliance Specialist

Job Description

We are seeking a dedicated and skilled Quality Control Compliance Specialist to lead compliance-related activities and tasks for our QC laboratory. The successful candidate will conduct laboratory investigations, author technical protocols and reports, perform data review and trend analysis, and provide timely escalation of compliance-related issues. This role requires flexibility in work schedule, including weekends, holidays, and overtime as needed.

Responsibilities

• Perform routine and process environmental monitoring in an aseptic manufacturing environment.
• Conduct clean utilities sampling and testing including compressed air, Nitrogen, WFI/DIW, and Clean Steam.
• Perform Bioburden, Endotoxin, Total Plate Count, Coliform, Bacteriostatic & Fungi stasis (B&F) and Biological Indicator testing, and Plate Reading.
• Write/review material specifications and perform material qualifications (media and reagents).
• Initiate and investigate microbiology-related deviations (NCEs), OOS investigations, and implement appropriate CAPAs as needed.
• Operate Sterility Isolator and perform routine maintenance and testing.
• Handle routine QC responsibilities such as sample coordination, peer review, lab equipment maintenance, QC document management, QC inventory control, and reconciliation of sample requests/documents.
• Monitor laboratory equipment for temperature, humidity, etc., and ensure conformance to specifications.
• Develop and troubleshoot microbiological methods for new products/components, author protocols and test methods.
• Act as a subject matter expert in one or more fields of microbiology (e.g., BET, Bioburden Testing, AET, Microbial Identification, Sterility Testing, LIMS).
• Serve as Lead investigator and writer for lab-related issues, conduct formal investigations, and ensure timely completion per quality systems and procedures.
• Communicate OOS findings immediately to Site Leadership and act with a sense of urgency to investigate.
• Assure all exception documentation adequately addresses root cause, corrective & preventive actions, and product impact.
• Develop, implement, manage, and track the effectiveness of corrective action plans for exceptions.
• Participate in Quality Review Board representing the QC Laboratory.
• Coordinate and lead USP/EP/ICH Committee to assess and trigger change implementation to remain in compliance.
• Assist with GMP Compliance program in the QC Laboratory, including managing training records, internal and self-audits, compliance walk-throughs, SOPs and Methods, deviation reduction initiatives.

Essential Skills

• Bachelor’s Degree in a scientific/technical discipline
• Minimum of 3 years of industry experience with at least one in QC Laboratory settings
• Expertise in performing laboratory investigations, change controls, and associated CAPA under limited guidance
• Working knowledge in Labware LIMS configuration of new analyses and product specifications
• Working knowledge of analytical method development, transfer, and validation methodologies and relevant guidance
• Knowledge of USP/EP/cGMP and ICH guidelines
• Experience with Laboratory Information Management System (LIMS)
• Proficiency in Global Quality Tracking System (TrackWise), Microsoft Office, Lean Six Sigma concepts, Lean Labs, project management, formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments

Additional Skills & Qualifications

• Experience with Micro tests in an Aseptic Processing company
• Proficiency in BET testing, Suitability Testing, Water/Bioburden Testing
• Experience writing deviations/Lab Events, updating SOPs, and working on CAPAs and Change Controls

Work Environment

The role requires the ability to stand on feet for up to four hours at a time, lift, push, and/or pull up to 25 pounds, and independently gown for aseptic processing. The candidate must meet minimal visual acuity requirements for quality assessments in a production or packaging environment and be able to move freely around a manufacturing environment, including stairs, ladders, and around machines with moving parts. Frequent standing, bending, stooping, and prolonged working overhead are required. Occasionally, the role involves ascending/descending a mezzanine staircase to take samples and performing close precision work with hands. Flexibility in work schedule, including weekends, holidays, and overtime, is required.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/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 Parsippany,NJ.

Application Deadline

This position is anticipated to close on Feb 21, 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 : $40 - $45