Job Title: Quality Assurance Specialist *Part time (25 hours/week)

Job Description

We are seeking a dedicated Quality Assurance Specialist to join our team. The successful candidate will be responsible for the review and approval of manufacturing release testing, stability batch records, supply chain documentation, and packaging & labeling activities. This role also includes reviewing and approving change controls, deviations, investigations, OOS/OOT, and supporting QA review of internal and external documentation for compliance with established standards and regulations.

Responsibilities

• Review 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 to ensure quality compliance with regulatory guidance and specifications.
• Support QA review of internal and external documentation for compliance with approved standards and regulations.
• Enter QMS data including complaints, OOS, investigations, and other activities as required.
• Perform other related tasks and projects as assigned.

Essential Skills

• Bachelor'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.
• Experience with electronic document systems such as Master Control.
• Excellent communication skills, both oral and written.
• Outstanding interpersonal skills and a collaborative approach.
• Self-motivated and comfortable in a fast-paced company environment.
• Working knowledge of cGMPs – FDA, EMEA.
• Ability to interpret analytical data.

Additional Skills & Qualifications

• Combination products/medical device experience is advantageous.
• Experience with electronic document systems like Master Control preferred.

Work Environment

The position is part-time, requiring availability for 5 hours per day, 5 days per week (25 hours per week total) during normal PST business hours. If local, the candidate should be open to coming onsite a couple of times per week. This role is ideal for someone specifically looking for part-time work, not interested in full-time employment at this time.

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 hybrid position in San Diego,CA.

Application Deadline

This position is anticipated to close on Feb 17, 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 : $60 - $65