Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Target Pay Rate: 25-32.77/hr **salary will be commensurate with experience
Job Description:
The Quality 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 quality 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.
MAJOR RESPONSIBILITIES:
Quality 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.
Quality 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.
Department Support
Participate in performance improvement projects.
Collaborate with other quality assurance positions within the organization.
Participate in department committees, teams, and workgroups.
Serve as a backup for quality and regulatory staff duties.
Complete ongoing training and professional development.
Qualifications:
Education - Bachelor’s Degree or higher in a science-based, quality, or engineering discipline - Formal Quality Training including statistical process control or quality related qualification a plus. Qualifications - A minimum of three years of professional experience in industry. - 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. Skills and Competencies - 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.
Compliance Specialist - I (Assistant)
727 Norristown Road Ambler, PA 19002 US
Posted: 08/28/2024
2024-08-28
2024-10-11
Employment Type:
Contract
Job Category: Other
Job Number: 613935
Is job remote?: No
Country: United States
Job Description
Target Pay Rate: 25-32.77/hr **salary will be commensurate with experience
Job Description:
The Quality 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 quality 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.
MAJOR RESPONSIBILITIES:
Quality 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.
Quality 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.
Department Support
Participate in performance improvement projects.
Collaborate with other quality assurance positions within the organization.
Participate in department committees, teams, and workgroups.
Serve as a backup for quality and regulatory staff duties.
Complete ongoing training and professional development.
Qualifications:
Education - Bachelor’s Degree or higher in a science-based, quality, or engineering discipline - Formal Quality Training including statistical process control or quality related qualification a plus. Qualifications - A minimum of three years of professional experience in industry. - 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. Skills and Competencies - 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.
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Ready to find your dream job in the vibrant area around Ambler, Pennsylvania? Nestled in Montgomery County, this picturesque town offers a perfect blend of small-town charm and big-city opportunities. With proximity to major cities like Philadelphia and New York City, Ambler provides a thriving job market with room for growth and advancement. Explore job opportunities in industries like healthcare, technology, education, and more while enjoying the eclectic dining scene along Butler Avenue or catching a show at the historic Ambler Theater. Take a break and unwind at Wissahickon Valley Park or appreciate local art at the Woodmere Art Museum. Join us in discovering all that Ambler, PA, has to offer – where your career can flourish amidst a backdrop of scenic beauty and cultural richness.
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
