Quality Control Technician II, Analytical

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

The Quality Control Technician II will be responsible for performing quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and procedures purchased components, manufactured sub-assemblies and final product. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing.

Responsible for performing Analytical testing such as TOC, Conductivity, Osmometry and pH testing.

Perform mechanical testing, DSC (Differential scanning calorimeter) and DBT (Burst testing).

Inspection and testing of raw materials, in-process, and final product testing.

Monitors equipment and instrumentation used daily to ensure proper operation and calibration.

Assists in the writing and updating of analytical test procedures, protocol, logbooks, and checklists.

Responsible for identifying and alerting a supervisor of issues on instruments and / or test executions; makes initial recommendations for possible solutions and / or corrective actions.

Develops and revises SOPs and trains appropriate new hires.

Maintains a working inventory of all components and archived materials and solutions as needed.

Assist as needed in test method validation, investigation studies or other product development studies.

Provides database support, generates reports, and analyzes the data as needed.

Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action / Preventive Actions (CAPAs).

Assist in preparing for and participating in FDA audits, customer audits, etc.

All other duties as assigned.

DESIRED MINIMUM QUALIFICATIONS :

The requirements listed below are representative of the knowledge, skill, and / or ability required for this position.

Bachelor's Degree in the biological or chemical sciences or equivalent with related work experience is required.

A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other cGMP regulated product preferred environment.

Familiarity with application of FDA and / or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.

Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

Experience with performing Instron, DSC and DBT testing preferred. Working knowledge of standard laboratory practices and safety.

Ability to follow instructions precisely, recognize deviations, and recommend corrective action.

Experience working in ISO Class 7 cleanrooms preferred.

Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

TOOLS AND EQUIPMENT USED :

Working knowledge and understanding of instruments including pH, Conductivity, Total Organic Carbon Water, Osmometry, Instron, Deferential Scanning Calorimeter, Identification of Raw Materials, and the visual inspection of raw material in-process and final product samples.

PHYSICAL REQUIREMENTS :

The physical requirements listed in this section include but are not limited to the motor / physical abilities and skills required of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must speak and write in English. The employee is required to go to all areas of the company. The employee may be required to periodically lift and / or move up to 25lbs.

ADVERSE WORKING CONDITIONS :

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

Salary Pay Range :

$26.21 - $35.38 USD Hourly

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency :

Subject to the terms of their respective plans, employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices :

EEO Is the Law () | EOE including Disability / Protected Veterans ()

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA () . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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