Jobs for People with MS: National MS Society

Job Title: Quality SpecialistJob Description

Manage Process Validation Documentation: Draft, review, and approve API Process Validation, Protocols, and Reports to ensure that documentation is in alignment with established procedures. Maintain the Periodic Review of the Validated Processes: Perform Annual Product Quality Reviews for Approved APIs as well as continuous statistical analysis of the processes. Assist with generating FMEA Risk Assessment in support of the Critical Process Parameters to support the Process Validation Reports. Collaborate with process development, manufacturing, and quality groups using principles of concurrent engineering to ensure manufacturability of the process. Support in-house manufacturing groups and/or client sites for scale-up and tech transfer of manufacturing processes. Assist with the Cleaning Validation Program and ensure adherence to Guidelines. Review and approve documentation related to Equipment Validation and Environmental Monitoring. Operate under cGMPs and perform additional Quality Assurance duties as necessary.

Responsibilities

• Draft, review, and approve API Process Validation, Protocols, and Reports.

• Perform Annual Product Quality Reviews for Approved APIs and continuous statistical analysis of the processes.

• Assist with generating FMEA Risk Assessment to support Process Validation Reports.

• Collaborate with process development, manufacturing, and quality groups to ensure manufacturability of the process.

• Support in-house manufacturing groups and/or client sites for scale-up and tech transfer of manufacturing processes.

• Assist with the Cleaning Validation Program and ensure adherence to Guidelines.

• Review and approve documentation related to Equipment Validation and Environmental Monitoring.

• Operate under cGMPs and perform additional Quality Assurance duties as necessary.

Essential Skills

• Quality assurance

• Validation

• API

• FDA

• Pharmaceutical

Additional Skills & Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.

• Minimum 5 years of experience in pharmaceutical manufacturing or a regulated environment; peptide manufacturing experience preferred.

• Knowledge of FDA, EU, and global GMPs including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11.

• Experience with Analytical Software (e.g. MiniTab).

Work Environment

Main work setting is an office environment. Occasionally, you will work in a cGMP-compliant manufacturing and lab environment requiring Personal Protective Equipment. Physical requirements include the ability to sit at a desk for long periods of time and the capacity to lift or move light-to-moderate weight boxes.

Pay and Benefits

The pay range for this position is $40.86 - $42.30/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 San Diego,CA.

Application Deadline

This position is anticipated to close on Mar 25, 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.