Quality Assurance Specialist

Job#: 3021044

Job Description:

Apex Systems is looking for a Quality Assurance Operations Specialist for our client, a Biotechnology company, to provide quality oversight and technical support for GMP manufacturing activities, ensuring compliance throughout batch record review, deviation and investigation management, change control, CAPA closure, and product disposition. This role reviews QC testing data, OOS investigations, and vendor documentation; supports material inspection and release; prepares certificates of analysis and compliance; and collaborates with Manufacturing, QC, Materials Management, and external partners to ensure timely and compliant product release. The position also contributes to Quality Management System maintenance and improvement, supports risk management and change control governance, compiles and analyzes quality metrics, and authors or revises SOPs and technical documentation while applying sound judgment and problem-solving skills in a regulated environment.

Job Title: QA Specialist

Location: Philadelphia, PA

Hourly Rate: $35/hr W-2

Length: Contract

If you or someone you know is interested in hearing more please send all resumes to for immediate consideration.

Primary Duties

The Quality Assurance Operations Specialist will:

Performs work under general supervision.

Provide quality, technical support and oversight during manufacturing

activities.

Review executed batch records and evaluate product and facility deviations;

draw conclusions in terms of product disposition at Spark.

Open deviations as appropriate based upon Spark Manufacturing Team and/or

CMO notification; provide evidence of document closing at time of product

disposition.

Assure all deviation/investigations, change controls, CAPAs, and/or other

required documentation are completed and closed prior to material/lot

release.

Review and evaluate QC testing records and any associated OOS

investigations.

Review, write, revise, and approve SOP's, technical documents, and reports.

Perform inspection and release of materials used for production and review

vendor certificates for completeness / compliance against approved

specifications and collaborate with Material Management to release incoming

materials for production.

Compile and maintain metrics for testing results, quality documentation

closure, and disposition and evaluate trending data to identify any irregular

trends and notify management as required.

Provide administrative project management support for Quality Management

System integration and improvement projects.

Provide support for Quality Risk Management governance, including

maintenance of documentation, risk register, CAPA plans, etc.

Support coordination of site Change Control Review Board and change control

communications with third party license holder.

Prepare certificate of compliance (CoC) and/or certificate of analysis

(CoA) for products for clinical and/or commercial materials.

Other assigned responsibilities as established by the QA Operations Lead.

Education and Experience Requirements

Bachelor's Degree in scientific discipline;

Minimum of 3-5 years in a regulated manufacturing environment with exposure

to Quality and Manufacturing field.

Knowledge of Quality Systems such as Change Control, Investigations and

CAPA;

Ability to communicate effectively with wide range of personnel;

Technical writing skills related to investigation reports.

General working knowledge of relevant governmental regulations, cGMP and

guidelines.

Key Skills, Abilities, and Competencies

Works under general supervision

Strong attention to detail;

Ability to manage multiple priorities and tasks in a dynamic environment;

Proficiency with computer programs;

Ability to work effectively in a team environment

Ability to establish facts, define problems, collect data and draw valid

conclusions;

Ability to exercise judgment to determine appropriate corrective actions.

With guidance from senior dept members ability to create and organize cGMP

system procedures based on regulatory / compliance regulations.

Excellent written and verbal skills;

Ability to work and communicate with contract manufacturers and testing

organizations.

Complexity and Problem Solving

Ability to define problems, collect data, establish facts, and draw valid

conclusions;

Analysis and problem-solving skills, including but not limited to the

ability to review and analyze manufacturing, quality control and validation

data.

Ability to participate on cross-functional teams in root cause analysis and

solution identification.

Ability to work collaboratively in the process of conflict resolution for

resolve deviations, effective CAPA's, and identifying requirements to

implement changes in a controlled GMP environment

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.