Quality Assurance Manager
· Job Overview/Summary
o The Quality Assurance Manager is responsible for compliance and continuous improvement of the Quality Management System and ensures all requirements of product quality are consistently achieved. Ensures products are compliant with QA policies and procedures, cGMPs, SOPs, and is responsible for disposition of lots. Ensures completeness and accuracy of master batch records and investigations. Oversee development, implementation and management of QA programs and initiatives for GMP activities. Ensure all QA programs are aligned with applicable regulations, regulatory standards, and internal procedures. May serve as back-up for senior management where assigned and appropriate.
o Essential Functions and Responsibilities
§ Work with senior management and other Quality staff to oversee the maintenance and improvement of an FDA- and ISO-compliant Quality System for GMP activities.
§ Perform trending on Quality System; provides evaluation to Senior Management.
§ Create, revise, review, and approve quality-related documents, including but not limited to procedures, memoranda, protocols, batch records and reports.
§ Assist Manufacturing and QC Supervisors/Specialists in solving compliance errors detected during process and batch record review.
§ Participate in or lead cross-functional investigations assigned by upper management.
§ Must make effective decisions in timely manner and be focused on execution until completion.
§ Independently manage simple to complex discrepancies.
§ Lead, participate in, and provide leadership for projects designated by upper management.
§ Recognize trends, deviations, problems and promptly reports them to management.
§ Multitask and manage competing priorities while meeting production timelines.
§ Represent Quality Assurance at meetings.
§ May lead the creation of meaningful CAPA plans with the responsible parties, including reasonable completion dates.
§ Recognize need for investigation due to deviation from written procedures.
§ Perform assigned tasks and work to achieve company goals and department objectives.
§ Member of Quality Improvement teams to address Quality / process issues. Lead quality process improvements.
§ Ensure staff determine and define the root causes for investigations.
§ Oversee review and approval of analytical method validation program and product development data to support IVD applications.
§ Review SOPs to ensure compliance with applicable regulatory and corporate standards.
§ Support the preparation, coordination, and management of regulatory agency inspections.
§ Proficient with manufacturing operations and quality procedures to comply with regulations.
§ Responsible for the enforcement of quality standards and process controls.
§ Lead and/or respond to quality audits to assure conformance with regulatory and internal requirements. Has the skills necessary to conduct internal audits.
§ Perform assigned work in timely and safe manner conforming to regulatory, company, and compendial requirements.
§ Maintain a working knowledge of government and industry Quality standards.
§ Provide direct manufacturing QA support during internal/external regulatory inspections.
§ May Participate in QRB and other compliance meetings for ensuring compliance requirements are met.
§ This job description is subject to change at any time.
o Required Qualifications
§ Bachelor’s degree in Chemistry, Life Science, or related field required.
§ 7+ years’ in a cGMP/IVD environment or equivalent; 3+ years’ related molecular diagnostic manufacturing experience is desirable.
§ 4+ years’ supervisory experience required.
§ Experienced in training techniques.
§ Experience in quality assurance, quality control or packaging operations.
§ Prior experience with regulatory (FDA & ISO 13485) inspections.
§ Solid understanding and use of sampling techniques and principles.
§ Intermediate principles of mathematical and statical computations.
§ Must have proficiency in cGMP practices in an FDA regulated environment.
§ Must have SOP, investigation, and project protocol writing skills.
§ Must have an understanding of cGMPs, GDP, CFR, ISO and IVDR.
o Preferred Qualifications
§ Able to analyze and troubleshoot problems.
§ Able to effectively handle conflict/resolution situations between different departments and intra-department.
§ Ability to interpret quality standards for implementation including ability to manage systems or processes.
§ Ability to make sound decisions about scheduling, providing direction allocation of resources, managing priorities and work hours to meet business objectives.
§ Flexibility in problem solving and solid decision-making skills.
§ Ability to lead moderate to complex projects or systems.
§ Must have good verbal and written communication skills
§ Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
o Position Benefits
Applied BioCode, Inc. employment provides the opportunity to work in beautiful Santa Fe Springs, California. We offer full health benefits, paid vacation and sick leave, and market-competitive salaries to all our employees. In addition, Applied BioCode, Inc. provides a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results, and Integrity.
· Job Overview/Summary
o The Quality Assurance Manager is responsible for compliance and continuous improvement of the Quality Management System and ensures all requirements of product quality are consistently achieved. Ensures products are compliant with QA policies and procedures, cGMPs, SOPs, and is responsible for disposition of lots. Ensures completeness and accuracy of master batch records and investigations. Oversee development, implementation and management of QA programs and initiatives for GMP activities. Ensure all QA programs are aligned with applicable regulations, regulatory standards, and internal procedures. May serve as back-up for senior management where assigned and appropriate.
o Essential Functions and Responsibilities
§ Work with senior management and other Quality staff to oversee the maintenance and improvement of an FDA- and ISO-compliant Quality System for GMP activities.
§ Perform trending on Quality System; provides evaluation to Senior Management.
§ Create, revise, review, and approve quality-related documents, including but not limited to procedures, memoranda, protocols, batch records and reports.
§ Assist Manufacturing and QC Supervisors/Specialists in solving compliance errors detected during process and batch record review.
§ Participate in or lead cross-functional investigations assigned by upper management.
§ Must make effective decisions in timely manner and be focused on execution until completion.
§ Independently manage simple to complex discrepancies.
§ Lead, participate in, and provide leadership for projects designated by upper management.
§ Recognize trends, deviations, problems and promptly reports them to management.
§ Multitask and manage competing priorities while meeting production timelines.
§ Represent Quality Assurance at meetings.
§ May lead the creation of meaningful CAPA plans with the responsible parties, including reasonable completion dates.
§ Recognize need for investigation due to deviation from written procedures.
§ Perform assigned tasks and work to achieve company goals and department objectives.
§ Member of Quality Improvement teams to address Quality / process issues. Lead quality process improvements.
§ Ensure staff determine and define the root causes for investigations.
§ Oversee review and approval of analytical method validation program and product development data to support IVD applications.
§ Review SOPs to ensure compliance with applicable regulatory and corporate standards.
§ Support the preparation, coordination, and management of regulatory agency inspections.
§ Proficient with manufacturing operations and quality procedures to comply with regulations.
§ Responsible for the enforcement of quality standards and process controls.
§ Lead and/or respond to quality audits to assure conformance with regulatory and internal requirements. Has the skills necessary to conduct internal audits.
§ Perform assigned work in timely and safe manner conforming to regulatory, company, and compendial requirements.
§ Maintain a working knowledge of government and industry Quality standards.
§ Provide direct manufacturing QA support during internal/external regulatory inspections.
§ May Participate in QRB and other compliance meetings for ensuring compliance requirements are met.
§ This job description is subject to change at any time.
o Required Qualifications
§ Bachelor’s degree in Chemistry, Life Science, or related field required.
§ 7+ years’ in a cGMP/IVD environment or equivalent; 3+ years’ related molecular diagnostic manufacturing experience is desirable.
§ 4+ years’ supervisory experience required.
§ Experienced in training techniques.
§ Experience in quality assurance, quality control or packaging operations.
§ Prior experience with regulatory (FDA & ISO 13485) inspections.
§ Solid understanding and use of sampling techniques and principles.
§ Intermediate principles of mathematical and statical computations.
§ Must have proficiency in cGMP practices in an FDA regulated environment.
§ Must have SOP, investigation, and project protocol writing skills.
§ Must have an understanding of cGMPs, GDP, CFR, ISO and IVDR.
o Preferred Qualifications
§ Able to analyze and troubleshoot problems.
§ Able to effectively handle conflict/resolution situations between different departments and intra-department.
§ Ability to interpret quality standards for implementation including ability to manage systems or processes.
§ Ability to make sound decisions about scheduling, providing direction allocation of resources, managing priorities and work hours to meet business objectives.
§ Flexibility in problem solving and solid decision-making skills.
§ Ability to lead moderate to complex projects or systems.
§ Must have good verbal and written communication skills
§ Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
o Position Benefits
Applied BioCode, Inc. employment provides the opportunity to work in beautiful Santa Fe Springs, California. We offer full health benefits, paid vacation and sick leave, and market-competitive salaries to all our employees. In addition, Applied BioCode, Inc. provides a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results, and Integrity.