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SUPERVISION RECEIVED

Reports to the Quality Control Senior Manager.

SUPERVISION EXERCISED

This position has no direct supervisory responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

Ensure all quality documentation is properly updated and completed in timely manner.Collaborate with Quality Management to ensure all quality standards are met.Provide support as needed for validations that involve microbiological testing, including EMPQ and Utilities qualifications.Product testing, monitoring support, Lab supplies purchasing, and laboratory projects.Data entry and review.Send out samples for external lab testing.Perform and support investigating non-conformances, identifying root causes, and implementing corrective actions.Document and report quality control findings and support the analysis of data to recommend process improvements.Prepare and/or support trending reports for quality control testing, environmental monitoring, and other laboratory testing as required.Assist in training employees on quality standards, KPIs and procedures.Support the implementation of new or improved quality control systems as needed.Ensure compliance with industry regulations, company policies, and safety standards during the transition process.Knowledge of industry standards and regulations related to Quality Control.Maintains work areas and equipment in a clean and orderly condition. Must be able to work in a Team environment, multi-task and communicate effectively.Maintains a working inventory of all components and archived materials and solutions.Assist as needed in test method validation, implementation, and execution.Provides database support, generate reports and analyze process data.Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits.Demonstrate excellent organizational and time management skills.Establish and maintain effective working relationships with those contacted in the course of work, work independently and in a team environment.Perform other duties as required.

DESIRED MINIMUM QUALIFICATIONS

Bachelor’s degree in Chemistry, Biology or related field.5+ years of relevant GMP/GLP laboratory experience in regulated industry.NOTE: Additional years of work experience or combination of additional years of work experience and Associate degree/certificates can substitute for Bachelor degree.Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.Knowledge of QC terms, tools, and methodologies. Detail-oriented.Strong verbal and written communication skills. Must be able to effectively present at staff and department meetings.Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.Working knowledge of standard Laboratory Practices and Safety.Ability to follow instructions precisely, recognize deviations, and recommend corrective action.

TOOLS AND EQUIPMENT USED

Calipers, rulers, dataloggers, standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, other general office equipment), and Lab equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required in order 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 repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. 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 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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.

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

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

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 or call us at 855-936-2666.

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