Lead Quality Systems - Site at QuVa Pharma
Bloomsbury, NJ 08804
About the Job
Our Lead Quality Systems Specialist plays a vital role in ensuring the highest quality of customer service within our finance department. Once you complete our training, your responsibilities will include providing support and subject matter expertise within areas of the Quality Management System (QMS)
Operates within legal and regulatory compliance, producing a quality product
Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.What the Lead Quality Systems – Site Does Each Day:Oversees printing and storing of batch recordsManages all GMP site records, including storing and retrievalLeads Quality System Specialist on daily tasksActs as site Document Administrator in QMS (MasterControlAssists QMS processes in electronic system (MasterControl)Assists during site inspectionsAnswers, evaluates and prioritizes incoming requests from users experiencing problems with creation of documents in QMS (MasterControl)Trains users on the use of the QMS tool (MasterControl)Recognizes necessary changes to the QMS processes and makes suggestions to improve themSupports failure and discrepancy investigations and documenting investigations on process deviationsMaintains compliance with FDA 503B and cGMP guidelines, P&P, USP 797, state and federal lawsAssists in developing policies and proceduresOur Most Successful Lead Quality Systems – Site:Is attentive to all aspects of the system while working to monitor and solve routine activities/issuesUses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, or other problem-solving tools in data analysis or in generating solutions; works effectively in a team environment with great organization skillsIs proficient in the use of office applications such as MS Word, Excel, PowerPointDemonstrates initiative and accountability in a fast-paced environment; Can make decisions quickly on available information and take action; makes commitments and does not change decisions when challenged; deals with emergencies as necessaryHas excellent verbal and written communication skills; good negotiating skills and influences others when conducting follow-upMaintains a mature problem-solving attitude while dealing with interpersonal conflict, complex environments, or time demandsWorks independently and follows good documentation practices and business rules for management of documents and records used in a regulated environmentDemonstrates leadership skills through exampleStarts and persists with specific courses of action while exhibiting high motivation and a sense of urgency to exceed internal customer satisfactionMinimum Requirements for this Role:High school Diploma or GED from recognized institution or organization requiredBachelor’s degree in business, Engineering, or related field plus 2 years’ experience managing documents and records in a regulatory or controlled environment; or, 4 + years relevant work experience will be consideredDemonstrated performance with direct supervision of a team is requiredMust be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge: Knowledge of business computer applications (e.g
MasterControl, Documentum, SAP, LIMS, Track wise, etc.)2 years’ experience in Quality Assurance / cGMP / FDA regulated industryBenefits of Working at QuVa:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout QuVa:QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care
We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide
As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment
QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws
All employment with QuVa is “at will.”Job SummaryRequisition Number: LEADQ005000Job Category: Site Quality SystemsSchedule: Full-Time
Operates within legal and regulatory compliance, producing a quality product
Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.What the Lead Quality Systems – Site Does Each Day:Oversees printing and storing of batch recordsManages all GMP site records, including storing and retrievalLeads Quality System Specialist on daily tasksActs as site Document Administrator in QMS (MasterControlAssists QMS processes in electronic system (MasterControl)Assists during site inspectionsAnswers, evaluates and prioritizes incoming requests from users experiencing problems with creation of documents in QMS (MasterControl)Trains users on the use of the QMS tool (MasterControl)Recognizes necessary changes to the QMS processes and makes suggestions to improve themSupports failure and discrepancy investigations and documenting investigations on process deviationsMaintains compliance with FDA 503B and cGMP guidelines, P&P, USP 797, state and federal lawsAssists in developing policies and proceduresOur Most Successful Lead Quality Systems – Site:Is attentive to all aspects of the system while working to monitor and solve routine activities/issuesUses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, or other problem-solving tools in data analysis or in generating solutions; works effectively in a team environment with great organization skillsIs proficient in the use of office applications such as MS Word, Excel, PowerPointDemonstrates initiative and accountability in a fast-paced environment; Can make decisions quickly on available information and take action; makes commitments and does not change decisions when challenged; deals with emergencies as necessaryHas excellent verbal and written communication skills; good negotiating skills and influences others when conducting follow-upMaintains a mature problem-solving attitude while dealing with interpersonal conflict, complex environments, or time demandsWorks independently and follows good documentation practices and business rules for management of documents and records used in a regulated environmentDemonstrates leadership skills through exampleStarts and persists with specific courses of action while exhibiting high motivation and a sense of urgency to exceed internal customer satisfactionMinimum Requirements for this Role:High school Diploma or GED from recognized institution or organization requiredBachelor’s degree in business, Engineering, or related field plus 2 years’ experience managing documents and records in a regulatory or controlled environment; or, 4 + years relevant work experience will be consideredDemonstrated performance with direct supervision of a team is requiredMust be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge: Knowledge of business computer applications (e.g
MasterControl, Documentum, SAP, LIMS, Track wise, etc.)2 years’ experience in Quality Assurance / cGMP / FDA regulated industryBenefits of Working at QuVa:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout QuVa:QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care
We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide
As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment
QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws
All employment with QuVa is “at will.”Job SummaryRequisition Number: LEADQ005000Job Category: Site Quality SystemsSchedule: Full-Time
