Compliance Specialist - I (Assistant) - On-Board Companies
Lower Gwynedd Township, PA 19002
About the Job
On-Board Scientific is hiring a Quality Compliance Specialist – Level I based out of Lower Gwynedd Township, PA!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located.
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located.
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Job Title: Quality Compliance Specialist I
Position Type: 1-year contract with additional opportunity contingent upon performance and continued business need.
Job Location: Lower Gwynedd Township< PA
Shift: 1 st shift
Compensation: $34.75 per hour.
The Compliance Specialist for Bioanalytical Data and Lab Systems will play a critical role in ensuring compliance with policies, quality standards, workflow procedures, and regulatory and accreditation requirements. This position will be responsible for conducting compliance audits of scientist/engineer records and lab systems, maintaining detailed auditing records, preparing trending reports, and monitoring auditing results to support optimal data integrity and continuous innovation and compliance. Additionally, the Compliance Specialist will contribute to performance improvement projects related to key department processes and serve as the department's compliance expert, supporting regulatory and accreditation survey activities.
Responsibilities:
Compliance Audits
- Conduct audits of scientist/engineer records to ensure completeness, accuracy, and appropriateness, including comparing source data to the records for accuracy and analyzing select data in detail.
- Audit department records and processes related to the bioanalytical data and lab systems, such as feedback surveys, after action reviews, and lab documentation.
- Prepare records for audits performed by other staff, such as supervisor reviews, project reviews, and internal audits.
- Identify opportunities for improving the quality and efficiency of records and processes.
- Participate in the preparation, facilitation, and follow-up activities for regulatory and accreditation surveys.
- Audit department records and processes related to general department functions, including training records, timekeeping, policy management, lab development plans/assessments/activities, and regulatory records.
- Complete audits according to an established schedule and procedures.
- Maintain detailed auditing data, including workload details and documented findings, recommendations, and corrections, for analytics.
- Inform and educate staff about audit findings, recommendations, and corrections.
- Report audit findings, recommendations, and corrections to internal leadership and complete follow-up activities as directed.
- Monitor and follow up on requested audit corrections to ensure completion. - Develop audit and documentation/recordkeeping policies, procedures, and workflows
Compliance Analytics
- Utilize tools, systems, and methods to organize and catalog various auditing data.
- Perform data and statistical analysis on auditing data to generate metrics and other tracking and trending analytics.
- Interpret and monitor metrics and analytics to identify trends and compliance towards auditing goals, expectations, and benchmarks.
- Establish auditing goals, expectations, and benchmarks and ensure they are met or exceeded.
- Prepare and present analytics to internal leadership and external audiences.
Department Support:
- Serve as the department's Compliance Expert, providing coaching, mentoring, and training on proper documentation/recordkeeping best practices and auditing practices.
- Recommend, lead, and participate in performance improvement projects.
- Collaborate on quality initiatives within and across the regulated bioanalytics organization.
- Deliver training on compliance processes to new and current employees.
- Participate in department committees, teams, and workgroups.
- Serve as a backup for quality and regulatory staff duties.
- Complete ongoing training and professional development.
- Contribute to the maintenance of the Business Continuity Plan.
- Participate and Lead remediation efforts within the department
Qualifications:
- A Bachelor's degree in a relevant field such as Quality Assurance, Engineering, Chemistry, Biology, Compliance, or a related discipline.
- Formal Quality Training including statistical process control or quality-related qualifications is a plus.
- A minimum of 3 years of professional experience in compliance, regulatory affairs, or a related field.
- Strong knowledge and hands-on experience working with quality management systems, standards, and regulations relevant to the industry, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
- Proficiency in performing laboratory inspections, audits, investigations, root cause analyses, and corrective actions.
- Experience working with testing procedures, quality metrics, and statistical analysis.
- Familiarity with document control, change control, and risk management processes.
- Experience collaborating with cross-functional teams to ensure compliance and continuous improvement.
- Attention to detail when reviewing technical and other documentation for accuracy and completeness to ensure adherence to established standards and protocols; ability to ‘read for meaning’ and identify basic non-compliance issues.
- Strong analytical and problem-solving skills to identify, analyze, and resolve quality issues.
- Effective communication and interpersonal skills to work collaboratively with teams and stakeholders, and to provide clear and concise reports and documentation.
- Proficient in using tools to document and track quality data.
- Excellent written and verbal communication skills and the ability to positively influence others.
- Computer skills: High level of proficiency
- Excel, Word, Power Point, Outlook, LIMS
- Possess a sound and logical approach to problem solving.
- Must have good collaboration skills with team and stakeholders.
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-02147
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Source : On-Board Companies
