Sr. Quality Specialist

Job Title: Quality Assurance Specialist Job Description
The Quality Assurance Specialist supports Operations and Quality by ensuring compliance with regulatory requirements and driving continuous process improvements within a pharmaceutical or biotech environment. This role partners closely with the Quality function to respond to quality events, enhance processes, and maintain robust quality system standards in alignment with FDA regulations and cGMP requirements.
Responsibilities
- Support Operations and Quality teams in maintaining compliance with applicable regulatory requirements and internal quality standards.
- Partner closely with Quality personnel to investigate, document, and respond to quality events and deviations.
- Drive process improvements across operations and quality systems to enhance efficiency, consistency, and compliance.
- Maintain and update quality system documentation, ensuring accuracy, completeness, and alignment with regulatory expectations.
- Perform and support document control activities, including creation, revision, approval, and archiving of controlled documents.
- Contribute to CAPA (Corrective and Preventive Action) activities by documenting issues, analyzing root causes, and tracking implementation and effectiveness of actions.
- Support audit activities by preparing documentation, participating in audits, and addressing identified observations in collaboration with Quality.
- Apply cGMP principles to daily tasks and ensure that all operational and quality-related activities adhere to current good manufacturing practices.
- Use strong analytical skills to review data, identify trends, and recommend improvements to quality systems and processes.
- Ensure all quality-related records and documentation are complete, accurate, and maintained in accordance with regulatory and internal requirements.
Essential Skills
- Quality assurance experience in a pharmaceutical or biotech environment.
- Bachelors degree in Life Sciences or a technical field.
- Experience working with FDA regulations and regulatory compliance requirements.
- Strong documentation skills with a high level of attention to detail and accuracy.
- Strong analytical skills for evaluating data, identifying issues, and supporting process improvements.
- Knowledge of cGMP (current Good Manufacturing Practices) and their application in daily operations.
- Experience with CAPA (Corrective and Preventive Actions) processes and documentation.
- Experience with document control within a regulated quality system.
- Familiarity with audit processes and deviation management in a regulated environment.
Additional Skills & Qualifications
- Medical device industry experience is a plus, with a focus on pharmaceutical or biotech as a minimum requirement.
- Ability to collaborate effectively with cross-functional teams, particularly Operations and Quality.
- Strong organizational skills and the ability to manage multiple tasks and documentation requirements simultaneously.
- Clear written and verbal communication skills for documenting quality events and interacting with stakeholders.
- Proactive mindset toward identifying opportunities for process improvement and quality enhancement.
Work Environment
This position is based on-site, Monday through Friday on a first-shift schedule, in a facility of approximately 50 employees. The environment is a regulated pharmaceutical or biotech setting where adherence to FDA regulations and cGMP standards is essential. The role involves close collaboration with Operations and Quality teams and regular interaction with quality systems, documentation, and audit-related activities in a professional office and laboratory/manufacturing environment.
Job Type & Location
This is a Contract position based out of New Cumberland, PA.
Pay and Benefits
The pay range for this position is $42.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)
Job Type & Location
This is a Contract position based out of New Cumberland, PA.
Application Deadline
This position is anticipated to close on Nov 20, 2026.
Workplace Type
This is a fully onsite position in New Cumberland,PA. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.