Medical Device company in Northern New Jersey seeking a 6-12 month contractor to help support their Regulatory department!

Position Overview:

Support manufacturing of orthopedic medical device products pertaining to the sterilization and cleanliness of the devices. Assess the impact of manufacturing related changes on the sterilization and cleanliness attributes of finished medical device products. Familiar with cGMP/cGDP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA). Knowledgeable in scientific concepts, measures, and terminology. Able to understand and apply specific laboratory protocols. Performs QA/QC duties as required.

Responsibilities:

Author and execute protocols and final reports to assess impact of manufacturing related changes against cleanliness requirements for impacted medical devices. May provide analysis and evaluation of materials and products at all stages of development process.Help manage the execution microbiological and chemistry testing both internally and externally.Communicate and collaborate with project owners to obtain all necessary information for assessment. May entail communication with internal operations and/or external suppliers.Conducts work in compliance with cGMP/cGDP, safety and regulatory requirements.

Qualifications:

Knowledge of medical devices, concepts of manufacturing equipment, and/or sterilization preferred. Knowledge of cGMP/cGDP required. Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision. Must have effective verbal and written communication skills. Efficient computer skills with basic knowledge of Microsoft Office. (i.e. Word/PowerPoint/Excel/Outlook/Teams)B.S. degree in Biological Sciences or related field with minimum of 5 years of Quality Assurance and/or Sterility Assurance experience preferred.

Interview process:  Will be interviewing in-person

Duration:  Initially will be 6 months but as the project progresses it could go to the end of 2025.  Will not go beyond 2025.

Pay and Benefits

The pay range for this position is $65.00 - $80.00

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 Mahwah,NJ.

Application Deadline

This position will be accepting applications until Jan 16, 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.