Job Title: Quality Assurance Specialist
Job Description

We are seeking a Quality Assurance Specialist to support our manufacturing release testing and stability batch records. You will be responsible for reviewing and approving DS and DP batches at external manufacturing vendors, supply chain documentation, and packaging & labeling activities. Additionally, you will manage Change Controls, deviations, investigations, OOS/OOT, and Analytical Chemistry data from external vendors in the US and EU. Your role will ensure quality compliance to regulatory guidance and specifications. You will support QA reviews of internal and external documentation for compliance with approved standards and regulations, and handle QMS data entry including complaints, OOS, and investigations.

ResponsibilitiesReview and approve manufacturing release testing and stability batch records.Review DS and DP batches at external manufacturing vendors.Review supply chain documentation and packaging & labeling activities.Review and approve Change Controls, deviations, investigations, OOS/OOT.Review and approve Analytical Chemistry data/documentation from external vendors in the US and EU.Ensure quality compliance to regulatory guidance and specifications.Support QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.QMS data entry, including complaints, OOS, investigations, and other activities as required.Complete other related tasks and projects as assigned.Essential SkillsBachelor's degree with 3+ years of relevant experience in GMP Quality Assurance, Analytical Chemistry/Quality Control, Manufacturing/Supply Chain in the pharmaceutical industry or clinical setting.Understanding of clinical trial phases leading up to commercialization.Experience with multiple Analytical techniques such as HPLC, GC, FTIR.Experience working with small molecules and CMOs.Electronic document systems experience with Master Control.Working knowledge of cGMPs – FDA, EMEA.Ability to interpret analytical data.Additional Skills & QualificationsCombination products/medical device experience would be advantageous.Excellent communication skills, both oral and written.Outstanding interpersonal skills and a collaborative approach.Self-motivated and comfortable in a fast-paced company environment.Work Environment

This position is part-time, requiring availability for 5 hours per day, 5 days per week (25 hours per week total). The role operates during normal PST business hours, Monday to Friday. If you are local, you may need to come onsite a couple of times per week. Ideal candidates are specifically looking for part-time work and are not seeking full-time positions.

Pay and Benefits

The pay range for this position is $60.00 - $65.00/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 San Diego,CA.

Application Deadline

This position is anticipated to close on Mar 19, 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.