Quality Assurance Specialist 1 Jobs

Quality Assurance Specialist I

CooperSurgical, Inc

Remotely - USA

Job Summary:

The Quality Assurance Specialist I is an entry level quality professional that is responsible for quality oversight of processes in Quality Management Systems, operations, review and/or release of products. This role is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs, and work instruction. In this role the candidate will work with cross functional teams and acquire in depth knowledge of Quality and the importance of quality processes in patient care. 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.

Essential Functions

• Uses existing procedures to solve routine or standard problems.
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
• Supports basic improvement projects.
• Maintenance of Record Management, electronic Document Management System and update document binders, indexes, and documentation therein
• Support Quality Systems under the direction of Quality Assurance Manager
• Basic conceptual knowledge and practices associated with Document Review
• Perform compliance review on executed records for completeness of all required testing and documents for various processes.
• Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
• Supports Minor Non-conformance investigations which may contain basic root cause analysis.
• Follows written instructions in the routine review of laboratory records in accordance with site standard operating procedures, good documentation practices (GDP) and Quality Management Systems (QMS)
• Communicate and collaborates with appropriate staff and Project Teams regarding Document revision staff. Aid in writing, revising procedures and formatting.
• Maintain understanding of company standards, guidelines and QMS processes to support and help stakeholders with applicable instructions.
• Perform control processes such as data entry counting, verification, issuance, receipt, and reconciliation of any discrepancies.
• Recognizes errors in records and resolves them in a timely manner.

Qualifications

• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
• Ability to focus on important issues only. Risk based approach
• Applies a preventative instead of corrective approach Attention to Detail
• Empathetic and can evaluate likely reactions
• Must display eagerness to learn and continuously improve.
• Makes realistic estimates of time and resource requirements
• Demonstrates logic to back up decisions
• Takes responsibility for improvements or solving problems.
• Regularly refocuses on results
• Demonstrates a drive to exceed performance targets
• Prioritizes and monitors tasks progress
• Able to make decisions quickly where necessary, based on incomplete information
• Excellent critical analytical skills – ability to find root cause of why and issue occurred.
• Identifies ways to improve processes/situations
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Socially capable - interacts confidently, reads the situation
• OR two to three years related experience and/or training; or equivalent combination of education and experience.
• Understands the drivers of change and anticipates the implications of changing political and practical circumstances
• Positive work attitude that supports teamwork and continuous improvement.
• Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
• Makes pragmatic decisions based on range of factors
• Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
• 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.
• Responds effectively to changing constraints.
• Knowledge of Master Control, or similar eQMS a plus
• Checks information, picks up inconsistencies and mistakes and can make detailed comparisons between similar sources
• Collaborative approach
• Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with one to three years related experience and/or training.
• Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
• Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal Skills

About CooperSurgical:

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

Our Benefits:

For U.S. locations that require disclosure of compensation, the starting hourly base pay for this role is between $35 and $50. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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.