Easter Seals Jobs

Job Title: Quality Systems & Compliance Contractor

Job Description

This position will support in product complaint handling including but not limited to: intake of Product Complaints from secured access mailbox, performing weekly and monthly product complaint reconciliations with vendors, partners, affiliates, and Drug Safety & Pharmacovigilance, assisting in providing product complaint metrics reports, developing training on product complaint handling, assisting with revision of product complaint SOPs/WI, archiving product complaints in accordance with policies, supporting Vendor and Audit team with document control tasks, and supporting regulatory inspection preparation and onsite during inspections as required. This position will be a hybrid role including both remote and onsite days.

Responsibilities

• Intake of Product Complaints from secured access mailbox.

• Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates, and Drug Safety & Pharmacovigilance.

• Assist in providing product complaint metrics reports.

• Develop training on product complaint handling.

• Assist with revision of product complaint SOPs/WI.

• Archive product complaints in accordance with policies.

• Support Vendor and Audit team with document control tasks.

• Support regulatory inspection preparation and onsite during inspections as required.

Essential Skills

• Prior experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.

• Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.

• Experience with the person and Veeva eQMS a plus.

• B.S. degree in life sciences, chemistry, or engineering or equivalent.

• Minimum of 5 years experience in Pharmaceutical Quality or Regulatory.

Additional Skills & Qualifications

• Knowledge of Vendor and/or Audit documentation a plus.

Work Environment

This position will be a hybrid role including both remote and onsite days.

Pay and Benefits

The pay range for this position is $55.00 - $66.00

• 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 hybrid position in Cambridge,MA.

Application Deadline

This position will be accepting applications until Dec 4, 2024.

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.