Quality Assurance Specialist II

Job Summary

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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.

• 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.

• Owner of Quality Management Processes such as:

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.

Knowledge, Skills and Abilities:

• 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.

Computer Skills

• Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.

• Proficiency with statistical software such as Minitab, R, or Matlab.

• Knowledge of Master Control, or similar eQMS a plus

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

Measurement System Analysis

• Capable of employing statistical methods for measurement system analysis

• Experience with analytical instrumentation preferred

Adaptability

• 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

Decision Making

• 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.

Initiative

• Attention to detail

  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

Interpersonal Skills

• 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

Results Oriented

• 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

Task Management

• 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

Work Environment:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision.

Education:

• 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

Experience

• Candidates must show knowledge and proficiency in the Quality Assurance Specialist II role

• 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

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

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.