BEPC Inc. - Business Excellence Professional Consulting · 2 hours ago
Quality Assurance Specialist
Philadelphia, PA
Contract
Onsite
Mid Level
$38.71/hr - $41.71/hr
3+ years expBEPC Inc. is a consulting and staffing solutions provider in the life sciences and technology industries. They are seeking an experienced Quality Assurance Specialist to support Quality Operations within a regulated manufacturing environment, focusing on quality oversight for manufacturing activities and compliance with regulatory requirements.
BiotechnologyConsulting
Hiring Manager
Paola Borrero
Responsibilities
Provide quality, technical support and oversight during manufacturing operations
Review executed batch records and assessed deviations to support product disposition decisions
Open deviations as required and ensure documentation is completed and closed prior to lot release
Ensure deviations, investigations, change controls, CAPAs, and related documentation are completed and closed in a timely manner
Review QC testing records and evaluate OOS investigations as applicable
Review, write, revise, and approve SOPs, technical documents, and quality reports
Perform inspection and release of incoming materials used in production
Review vendor Certificates of Analysis (CoA) and Certificates of Compliance (CoC) for completeness and specification compliance
Collaborate with Material Management to release incoming materials for manufacturing use
Compile and maintain quality metrics related to testing, documentation closure, and product disposition
Analyze and trend quality data to identify potential issues and notify management of irregular trends
Provide administrative and project support for Quality Management System integration and continuous improvement initiatives
Support Quality Risk Management activities, including maintenance of risk registers and CAPA plans
Support Change Control Review Board activities and related communications with third-party partners
Prepare CoAs and CoCs for clinical and/or commercial products
Perform additional duties as assigned by the QA Operations Lead
Qualification
Required
Bachelor's degree in a scientific discipline
3–5 years of experience in a regulated manufacturing environment with exposure to Quality Assurance and Manufacturing
Working knowledge of Quality Systems including Deviations, Investigations, Change Control, and CAPA
General understanding of cGMP regulations and applicable governmental guidelines
Strong technical writing skills, particularly for investigations and quality documentation
Ability to communicate effectively with cross-functional teams and external partners
Strong attention to detail and commitment to data integrity
Ability to manage multiple priorities in a fast-paced environment
Proficiency with standard computer applications and quality systems
Ability to work effectively both independently and in a team environment
Strong analytical and problem-solving skills, including data review and trend analysis
Sound judgment in determining appropriate corrective and preventive actions
With guidance, ability to develop and organize cGMP system procedures
Excellent written and verbal communication skills
Experience working with contract manufacturers and external testing organizations
Ability to define problems, collect and analyze data, and draw valid conclusions
Participate in cross-functional root cause investigations and solution development
Collaborate effectively to resolve deviations, implement CAPAs, and manage changes within a controlled GMP environment
100% onsite role in a regulated GMP manufacturing environment
Frequent interaction with internal departments including Manufacturing, Quality Control, and Facilities, as well as external vendors and partners
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
201-500 employees
H1B Sponsorship
BEPC Inc. - Business Excellence Professional Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Oscar Casillas
President and CEO
Andrew Casillas
Human Resources Partner
Company data provided by crunchbase