BioSpectra, Inc. · 4 hours ago
Quality Assurance Manager
Bangor, PA
Full-time
Onsite
Senior Level
$75K/yr - $90K/yr
5+ years expBioSpectra, Inc. is a growing bio-pharmaceutical manufacturer looking for a Quality Assurance Manager to lead quality assurance, regulatory, and environmental programs. The role involves maintaining the quality management system, overseeing compliance inspections, managing customer complaints, and ensuring regulatory compliance for the Dextran Product's facility.
ChemicalManufacturingPharmaceutical
Responsibilities
Maintain and implement the requirements of the quality management system throughout the facility and processes
Review raw material testing record and issues material disposition. Manages raw material supplier qualification process
Issue and approve material disposition. Approve product related records, analysis request and BOMs in Sage
Issue, Review and approve batch production records, reviews finished product results documentation, analysis record and issues and approves Certificate of Analysis (C of A), and prepares and issues labels for final release
Perform recurring quality inspection of the facility to ensure compliance to standards, applicable regulations and internal procedures. Ensure facility is maintained and systems are clean and ready for use through inspection, providing recommendations, communicating findings and tracking completion of corrections
Prepare, review, revise and approve documentation and procedures including blank product batch records, SOPs, test records and analysis, log books, instrument calibration reports, IQ/OQ protocols
Review and Approve GMP records including batch records, forms, log books, laboratory records, investigations, CAPAs and other forms of GMP documentation. Ensure that documents are retained in accordance with the Company policies and Quality Management System
Manage CAPA & internal audit programs; and lead out-of-specification investigations
Manage Change Control process, determine change classification and initiate customer notification
Manage customer complaint process, lead customer audits, including generating audit responses and CAPA, complete customer questionnaires and investigate and manage product recalls
Host and prepare for customer and regulatory audits
Develop program with procedure/protocols, monitor conditions, review on-going sampling results, investigate OOS results and establish product shelf life
Manage Dextran's regulatory program to ensure compliance with internal SOPs and external regulations
Ensure accurate and complete documentation is provided in support of product commercialization
Perform annual product reviews, generate reports based on in-process and finished product analysis
Ensure compliance to environmental policy and reporting requirements. Ensure compliance to the company’s health and safety programs through procedure review and approval. Perform safety inspections during the required frequency, document and communicate findings and ensure corrective and preventative actions are completed in a timely manner
Conduct training for new hires, training on SOPs and changes, retraining and quality systems training
Manage, review and approve documentation related to the plant's pest control program
Qualification
Required
Bachelor's degree in Chemistry, Chemical Engineering or related field or the equivalent in related experience
Five or more years of experience managing multiple elements of a quality assurance and/or compliance program within a GMP chemical manufacturing facility
Familiarity with IPEC regulations and guidelines
Experience understanding and working with chemical compounds and ingredients as well as resolving issues related to chemical manufacturing
Demonstrated working knowledge of quality assurance programs and regulatory requirements
Ability to create, review and implement procedures and documentation that ensure regulatory compliance
Ability to handle customer complaints, investigations and effectively communicate the results
Capability to build an internal audit program that will ensure compliance with regulatory, quality assurance, environmental, health and safety programs
Accountability for quality assurance, including reviewing and interpreting batch records and lab testing data
Leadership capability to direct plant staff and work collaboratively with multiple stakeholders
Effective communication skills to convey information to individuals both inside and outside the organization
Ability to effectively organize responsibilities to meet commitments to the organization and customers
Ability to effectively train employees
Problem-solving and decision-making skills to take decisive action after assessing situations
Company
BioSpectra, Inc.
BioSpectra Inc.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2023-08-09
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