What are the responsibilities and job description for the Quality and Regulatory Specialist position at MEA - MidAtlantic Employers’ Association?
Job Description
Quality and Regulatory Specialist
Philadelphia, PA
We are seeking an experienced Quality and Regulatory Specialist to join our Team.
This is a full-time, permanent position, working in a hybrid fashion.
Role
The role overview is as follows:
Responsibility for ensuring the companys products and processes comply with all relevant regulatory standards, including FDA regulations, by monitoring quality control procedures, investigating non-conformances, maintaining documentation, and collaborating with cross-functional teams to uphold the highest quality standards across the manufacturing and distribution of chemical products, while actively identifying and addressing potential regulatory risks within the industry.
Youll support regulatory compliance and quality assurance efforts within manufacturing, chemical, personal care, and related manufacturing industries.
Key Responsibilities
Quality Assurance Monitoring:
Conduct routine quality checks on raw materials, in-process products, and finished goods to ensure compliance with specifications and standards.
Review and approve manufacturing documentation, including batch records, test results, and labeling to guarantee accuracy and adherence to procedures.
Investigate and document non-conforming products, initiating corrective actions and preventive measure (CAPA) as needed.
Regulatory Compliance
Stay updated on relevant regulatory requirements and industry trends, including FDA regulations, to ensure our organization remains compliant.
Assist in the preparation and submission of regulatory filings, such as product registrations, safety reports, and labeling updates.
Conduct internal audits to assess compliance with the quality system and regulatory standards.
Documentation And Reporting
Maintain comprehensive documentation of quality control activities, including test results, deviations and corrective actions.
Prepare reports on quality metrics and trends for management review and continuous improvement.
Prepare reports on quality metrics and trends for management review and continuous improvement.
Updated and maintain Standard Operating Procedures (SOP) to reflect current practices and regulatory changes.
Cross-Functional Collaboration
Work closely with production teams to identify and address quality issues throughout the manufacturing process.
Collaborate with the Quality Assurance team to implement quality improvement initiatives.
Coordinate with the regulatory affairs department on regulatory compliance matters.
Supplier Management
Review supplier documentation and conduct supplier audits to ensure the quality of incoming raw materials.
Manage supplier relationships to address quality concerns and drive continuous improvement.
We are a well-established organization and offer a very supportive team and work/life culture.
We ask that you be available to work on-site three (3) days per week.
Required Experience
Required Skills and Qualifications:
Bachelors degree in Chemistry, Biology or a related scientific field
Ten (10 ) years of related experience
Strong understanding of quality assurance principles and regulatory compliance requirements, particularly within the chemical manufacturing industry.
Experience with laboratory techniques and quality control procedures.
Excellent written and verbal communication skills to effectively document findings and communicate with cross-functional teams.
Strong analytical and problem-solving abilities to investigate and resolve quality issues.
Proficiency in Microsoft Office Suite and relevant Quality Management Systems.
Benefits
Comprehensive Salary and Full Benefits
Keyword: chemicals, manufacturing, nutraceuticals, personal care products
Quality and Regulatory Specialist
Philadelphia, PA
We are seeking an experienced Quality and Regulatory Specialist to join our Team.
This is a full-time, permanent position, working in a hybrid fashion.
Role
The role overview is as follows:
Responsibility for ensuring the companys products and processes comply with all relevant regulatory standards, including FDA regulations, by monitoring quality control procedures, investigating non-conformances, maintaining documentation, and collaborating with cross-functional teams to uphold the highest quality standards across the manufacturing and distribution of chemical products, while actively identifying and addressing potential regulatory risks within the industry.
Youll support regulatory compliance and quality assurance efforts within manufacturing, chemical, personal care, and related manufacturing industries.
Key Responsibilities
Quality Assurance Monitoring:
Conduct routine quality checks on raw materials, in-process products, and finished goods to ensure compliance with specifications and standards.
Review and approve manufacturing documentation, including batch records, test results, and labeling to guarantee accuracy and adherence to procedures.
Investigate and document non-conforming products, initiating corrective actions and preventive measure (CAPA) as needed.
Regulatory Compliance
Stay updated on relevant regulatory requirements and industry trends, including FDA regulations, to ensure our organization remains compliant.
Assist in the preparation and submission of regulatory filings, such as product registrations, safety reports, and labeling updates.
Conduct internal audits to assess compliance with the quality system and regulatory standards.
Documentation And Reporting
Maintain comprehensive documentation of quality control activities, including test results, deviations and corrective actions.
Prepare reports on quality metrics and trends for management review and continuous improvement.
Prepare reports on quality metrics and trends for management review and continuous improvement.
Updated and maintain Standard Operating Procedures (SOP) to reflect current practices and regulatory changes.
Cross-Functional Collaboration
Work closely with production teams to identify and address quality issues throughout the manufacturing process.
Collaborate with the Quality Assurance team to implement quality improvement initiatives.
Coordinate with the regulatory affairs department on regulatory compliance matters.
Supplier Management
Review supplier documentation and conduct supplier audits to ensure the quality of incoming raw materials.
Manage supplier relationships to address quality concerns and drive continuous improvement.
We are a well-established organization and offer a very supportive team and work/life culture.
We ask that you be available to work on-site three (3) days per week.
Required Experience
Required Skills and Qualifications:
Bachelors degree in Chemistry, Biology or a related scientific field
Ten (10 ) years of related experience
Strong understanding of quality assurance principles and regulatory compliance requirements, particularly within the chemical manufacturing industry.
Experience with laboratory techniques and quality control procedures.
Excellent written and verbal communication skills to effectively document findings and communicate with cross-functional teams.
Strong analytical and problem-solving abilities to investigate and resolve quality issues.
Proficiency in Microsoft Office Suite and relevant Quality Management Systems.
Benefits
Comprehensive Salary and Full Benefits
Keyword: chemicals, manufacturing, nutraceuticals, personal care products
