Quality Assurance Specialist
Company: TalentBurst, Inc.
Location: Philadelphia
Posted on: February 18, 2026
|
|
|
Job Description:
Job Description Job Description Quality Assurance Specialist
Philadelphia, PA 09 Months 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 Internal and External Contacts Peers and colleagues
throughout the organization as well as external, including
manufacturing, Quality Control, facilities and vendors. TB_PH ZR
Company Description Founded in 2002 by three former Monster.com
executives; TalentBurst is an award-winning full-service Staffing
Firm working directly with Fortune 500 companies in the US and
Canada. We specialize in Contract and Contract to Permanent roles
across many industries and have direct/contractual relationships
with all our clients. Please visit our website www.talentburst.com
or come meet us at our offices in Natick, MA, Miami, FL,
Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San
Francisco, CA Company Description Founded in 2002 by three former
Monster.com executives; TalentBurst is an award-winning
full-service Staffing Firm working directly with Fortune 500
companies in the US and Canada. We specialize in Contract and
Contract to Permanent roles across many industries and have
direct/contractual relationships with all our clients. Please visit
our website www.talentburst.com or come meet us at our offices in
Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston,
TX & downtown San Francisco, CA
Keywords: TalentBurst, Inc., Wayne , Quality Assurance Specialist, Science, Research & Development , Philadelphia, New Jersey
