CooperSurgical
Quality Assurance Specialist II
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.
Work location:
Houston, TX (on‑site). This is a contract‑only role for 9–12+ months. Job Summary
The Quality Assurance Specialist II is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs, including Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting, Document Control, Supplier Qualification, and Validations. The role also involves training personnel on the QMS, partnering with stakeholders to improve quality culture, and driving continuous improvement. Responsibilities
Provide quality oversight, support, and engagement as needed by Operations. Continuously observe processes, gather data for monitoring, and identify performance metrics. Coordinate reviews to gather input from contributing departments and track, trend, and report quality system metrics. Maintain a culture of quality awareness, teamwork, and cooperation with quality customers. Perform and/or facilitate testing for continuous improvement and investigations. Provide system visibility, communicate status, and close aging items. Work cooperatively in a team environment to maintain cross‑functional and cross‑site process consistency for quality system records. Create and implement a training program for the QMS processes to educate quality assurance customers. Perform additional duties and tasks as directed. Owner of Quality Management Processes : Review records from production, inspection, and testing for compliance. Document Control Program: review, approve, and maintain SOPs via the electronic Document Quality Management System. Change Management Program: review, approve, and track changes to processes, procedures, qualifications, validations, and equipment. Deviations and Nonconformances: document, analyze, review, approve, and monitor quality events and deviations. Supply/Vendor Management: supplier qualification, reassessment, quality agreements, and score cards. Validations: review and approval of equipment, systems, and any design transfer to operations. Quality Metrics: collect data, conduct analysis, and report trends for quality indicators. Compliance: audit plan and reporting, corrective action review, audit hosting and preparation. Qualifications
Knowledge, Skills and Abilities
Understand and apply comprehensive quality principles and maintain current understanding of regulations. Knowledge of basic statistics, risk tools, technical writing, and investigation review. Computer Skills
Proficiency in Microsoft Office (Word, Excel, PowerPoint). Proficiency with statistical software such as Minitab, R, or Matlab. Knowledge of Master Control or similar eQMS is a plus. Biological Systems
Familiarity with cell and molecular biology concepts. Understanding of biochemical concepts such as pH, stoichiometry, enzymatic catalysis. Measurement System Analysis
Capable of employing statistical methods for measurement system analysis. Experience with analytical instrumentation is preferred. Adaptability
Respond effectively to changing conditions and anticipate implications. Apply a preventative approach and identify inconsistencies and mistakes. Decision Making
Make pragmatic decisions based on multiple factors. Make decisions quickly when necessary, using logic to support decisions. Apply critical analytical skills to find root causes of issues. Initiative
Attention to detail and identify ways to improve processes. Takes responsibility for solving problems and displays eagerness to learn. Sets high standards and displays dissatisfaction with substandard activities. Interpersonal Skills
Interact confidently, read situations, and evaluate likely reactions. Collaborate effectively and maintain a positive work attitude that supports teamwork and continuous improvement. Results Oriented
Focus on important issues, employ a risk‑based approach, and achieve performance targets. Task Management
Handle multiple tasks and competing priorities efficiently. Prioritize tasks and monitor progress while making realistic estimates of time and resources. Work Environment
Physical demands include sitting, talking, hearing, standing, walking, using hands, reaching; specific vision ability required is close vision. Reasonable accommodations may be made for individuals with disabilities. Education
Bachelor’s degree (BA/BS) from a four‑year college or university required. Background in statistics, mathematics, engineering, chemistry, or biological sciences preferred. Or six to eight years related experience and/or training, or an equivalent combination of education and experience. Experience and Certifications
Knowledge and proficiency in the QA Specialist II role. Six Sigma training preferred. Quality management or quality engineer training is a plus. Knowledge of regulations and standards such as FDA (21 CFR 820), ISO 13485, ISO 15189, ISO 17025, ISO 9001, FDA (HCT/P, cGMP, cGTP). We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
#J-18808-Ljbffr
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.
Work location:
Houston, TX (on‑site). This is a contract‑only role for 9–12+ months. Job Summary
The Quality Assurance Specialist II is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs, including Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting, Document Control, Supplier Qualification, and Validations. The role also involves training personnel on the QMS, partnering with stakeholders to improve quality culture, and driving continuous improvement. Responsibilities
Provide quality oversight, support, and engagement as needed by Operations. Continuously observe processes, gather data for monitoring, and identify performance metrics. Coordinate reviews to gather input from contributing departments and track, trend, and report quality system metrics. Maintain a culture of quality awareness, teamwork, and cooperation with quality customers. Perform and/or facilitate testing for continuous improvement and investigations. Provide system visibility, communicate status, and close aging items. Work cooperatively in a team environment to maintain cross‑functional and cross‑site process consistency for quality system records. Create and implement a training program for the QMS processes to educate quality assurance customers. Perform additional duties and tasks as directed. Owner of Quality Management Processes : Review records from production, inspection, and testing for compliance. Document Control Program: review, approve, and maintain SOPs via the electronic Document Quality Management System. Change Management Program: review, approve, and track changes to processes, procedures, qualifications, validations, and equipment. Deviations and Nonconformances: document, analyze, review, approve, and monitor quality events and deviations. Supply/Vendor Management: supplier qualification, reassessment, quality agreements, and score cards. Validations: review and approval of equipment, systems, and any design transfer to operations. Quality Metrics: collect data, conduct analysis, and report trends for quality indicators. Compliance: audit plan and reporting, corrective action review, audit hosting and preparation. Qualifications
Knowledge, Skills and Abilities
Understand and apply comprehensive quality principles and maintain current understanding of regulations. Knowledge of basic statistics, risk tools, technical writing, and investigation review. Computer Skills
Proficiency in Microsoft Office (Word, Excel, PowerPoint). Proficiency with statistical software such as Minitab, R, or Matlab. Knowledge of Master Control or similar eQMS is a plus. Biological Systems
Familiarity with cell and molecular biology concepts. Understanding of biochemical concepts such as pH, stoichiometry, enzymatic catalysis. Measurement System Analysis
Capable of employing statistical methods for measurement system analysis. Experience with analytical instrumentation is preferred. Adaptability
Respond effectively to changing conditions and anticipate implications. Apply a preventative approach and identify inconsistencies and mistakes. Decision Making
Make pragmatic decisions based on multiple factors. Make decisions quickly when necessary, using logic to support decisions. Apply critical analytical skills to find root causes of issues. Initiative
Attention to detail and identify ways to improve processes. Takes responsibility for solving problems and displays eagerness to learn. Sets high standards and displays dissatisfaction with substandard activities. Interpersonal Skills
Interact confidently, read situations, and evaluate likely reactions. Collaborate effectively and maintain a positive work attitude that supports teamwork and continuous improvement. Results Oriented
Focus on important issues, employ a risk‑based approach, and achieve performance targets. Task Management
Handle multiple tasks and competing priorities efficiently. Prioritize tasks and monitor progress while making realistic estimates of time and resources. Work Environment
Physical demands include sitting, talking, hearing, standing, walking, using hands, reaching; specific vision ability required is close vision. Reasonable accommodations may be made for individuals with disabilities. Education
Bachelor’s degree (BA/BS) from a four‑year college or university required. Background in statistics, mathematics, engineering, chemistry, or biological sciences preferred. Or six to eight years related experience and/or training, or an equivalent combination of education and experience. Experience and Certifications
Knowledge and proficiency in the QA Specialist II role. Six Sigma training preferred. Quality management or quality engineer training is a plus. Knowledge of regulations and standards such as FDA (21 CFR 820), ISO 13485, ISO 15189, ISO 17025, ISO 9001, FDA (HCT/P, cGMP, cGTP). We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
#J-18808-Ljbffr