Job Title: Quality Systems Associate

Job Description

As a Quality Systems Associate, you will ensure compliance with cGMP standards in the Manufacturing and Packaging areas. You will be responsible for compiling and verifying production control records, ensuring laboratory release testing meets specifications, and coordinating resolutions for any excursions identified during the batch review process. Your role will also involve updating and managing documentation, including logbooks and notebooks, and adhering to customer release requirements.

Responsibilities

• Ensure compliance with cGMP standards in the Manufacturing and Packaging areas.
• Compile and verify the completeness and accuracy of all production control records.
• Ensure laboratory services release testing conforms to bulk and finished product specifications.
• Execute or coordinate resolutions for excursions identified during the batch review process.
• Issue and review logbooks and notebooks.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Adhere to customer release requirements.
• Update paper and electronic records.
• File and archive documentation.

Essential Skills

• Quality assurance
• Batch record review and release
• cGMP compliance
• Quality control
• Document control
• Adherence to Standard Operating Procedures and customer specifications

Additional Skills & Qualifications

• BS in Life Science (Chemistry, Biology, Biochemistry, etc.)
• Minimum of 6 months of experience within a cGMP environment
• Experience with documentation in a cGMP environment
• Familiarity with batch records review and/or release

Work Environment

The work environment is split between the office, packaging, and laboratory settings. The team currently consists of six members, with two on the first shift and three on the second shift. There is an opening for an additional position on the first shift, Thursday to Monday, with working hours from 8 am to 5 pm, including a 1-hour unpaid lunch break. Training will be conducted on the first shift from Monday to Friday.

Pay and Benefits

The pay range for this position is $20.00 - $22.00

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 Mainland,PA.

Application Deadline

This position will be accepting applications until Jan 28, 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 : $20 - $22