Quality Assurance Specialist II

CooperCompanies•Houston, TX

1d•Onsite

About The Position

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Houston, TX (on-site). This is a contract only role for 9-12+ months Scope: The Quality Assurance Specialist II reports to the Life Science Quality Manager/ Director. The role will maintain and develop Quality procedure(s), review and approve production lots for release, generate and analyze data for tracking and trending, and work with stakeholders to provide continuous improvement. The Specialist II will be responsible for training the organization on Quality System(s), Quality procedures, and mentoring less experienced team members. The individual will help drive change to prevent and remediate the risks to internal and external customers. Job Summary: The Quality Assurance Specialist II is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs. These include Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, and Validations. In this role, the candidate will train other personnel on the Quality System(s). The Quality Specialist II will partner with stakeholders to improve the quality program and quality culture within the organization. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Requirements

Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
Knowledge and experience with basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
Proficiency with statistical software such as Minitab, R, or Matlab.
Biological Systems Familiarity with cell and molecular biology concepts such as cell structure and DNA replication
Understands biochemical concepts such as pH, stoichiometry, enzymatic catalysis
Capable of employing statistical methods for measurement system analysis
Responds effectively to changing conditions and constraints
Understands the drivers of change and anticipates the implications of changing circumstances
Applies a preventative instead of corrective approach
Checks information, picks up inconsistencies, identifies mistakes, and can make detailed comparisons between similar sources
Makes pragmatic decisions based on range of factors
Able to make decisions quickly where necessary, based on incomplete information
Demonstrates logic to back up decisions
Excellent critical analytical skills – ability to find the root cause(s) of issues.
Identifies ways to improve processes/situations
Takes responsibility for improvements or solving problems.
Must display eagerness to learn and continuously improve.
Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities
Socially capable - interacts confidently, reads the situation
Empathetic and can evaluate likely reactions
Collaborative approach
Positive work attitude that supports teamwork and continuous improvement.
Ability to work effectively and efficiently in a team environment
Ability to focus on important issues only
Able to employ a risk based approach
Regularly refocuses on results
Demonstrates a drive to exceed performance targets
Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
Prioritizes and monitors tasks progress
Makes realistic estimates of time and resource requirements
Bachelor’s degree (BA/BS) from 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 equivalent combination of education and experience
Candidates must show knowledge and proficiency in the Quality Assurance Specialist II role

Nice To Haves

Experience with analytical instrumentation preferred
Knowledge of Master Control, or similar eQMS a plus
Six Sigma training preferred
Quality management or quality engineer training a plus
Candidate should demonstrate knowledge of regulations and standards such as: ☐ CLIA (42 CFR 493) Laboratory Requirements ☒ FDA (HCT/P, cGMP, cGTP) ☒ FDA (21 CFR 820) Quality System Regulation ☐ FDA (21 CFR 1271) Human Cells, Tissues, and Cellular and Tissue-Based Products ☐ FACT standards, Foundation for Accreditation of Cellular Therapy ☒ ISO 13485 Medical Devices Quality Management ☒ ISO 15189 Medical Laboratories ☒ ISO 17025 Testing and Calibration Laboratories ☒ ISO 9001 Quality Management Systems ☐ AABB standards ☐ AATB standards

Responsibilities

Provide Quality oversight, support, and engagement as needed by Operations
Continuously observe processes and gather data for monitoring
Identify performance metrics based on direct observation, trending, and quality events
Coordinate reviews to gather input from various contributing departments.
Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating quality and compliance risks.
Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
Performs and/or facilitates 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 processes and procedural consistency for quality systems records.
Create and implement a training program for the QMS processes to educate Quality Assurance customers.
Perform other duties and tasks as directed.
Review records from production, inspection, and testing processes for accuracy and completeness to assure compliance with all relevant specifications, procedures, and policies. Certify the quality of acceptable analyses and conformance.
Document Control Program: review, approval, and maintenance of company Standard Operating Procedures via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.
Change Management Program: Review, approve, and track changes to processes, procedures, qualifications, validations, and equipment. Execute, track, and verify action items within a cross-functional team to implement controlled changes.
Deviations and Nonconformances: Document, analyze, review, approve, and monitor quality events and deviations. Handle complaints, nonconformances, and CAPA’s. Perform investigation tasks, track activities for record keeping, and facilitate cross-functional efforts to prevent and mitigate risks to internal and external stakeholders.
Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.
Validations: Review and approval of equipment, systems validation/ qualification, and any design transfer to operations
Quality Metrics: Collect data, conduct analysis, and report trends for quality indicators. Identify quality metrics, risks, and improvements to improve process control.
Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. Aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.