JOB DESCRIPTION



General Summary:

Leads laboratory activities including testing and project management activities designed to ensure current and future product and material adherence to established quality system requirements, FDA, CMDR, MDD, and other applicable regulatory/statutory or ISO requirements for new and existing products and materials. Also, manages laboratory equipment and materials.

Key Responsibilities:

Supervisory Responsibilities:

• Establish clear measurable goals and objectives by which to determine individual and team results (i.e. Lab metrics, results against project timelines)

• Train laboratory personnel to understand equipment and methodologies, and ensure they follow test protocols appropriately.

• Develops and implements methods and procedures for monitoring work activities, such as preparation of records, progress reports, etc., in order to inform management of current status of work activities.

• Ensure that laboratory test methods used are current

• Organizes training activities related to good laboratory practices (GLP).

• Reviews/approves protocols, writes technical reports and procedures.

Functional & Tactical Responsibilities:

• Responsible for Stability Testing Program.

o Drafts and executes stability testing protocols for new and existing products.

o Provides periodic summaries of ongoing stability projects

o Provides a summary upon completion of all stability projects

• Responsible for coordinating Sterilization Validations for Sarasota manufactured product and assisting Juarez site with sterilization validation activities as needed. In this role, responsible for drafting and executing validation protocols to meet the requirements under AAMI 11135 Sterilization of Health Care Products using Ethylene Oxide.

• Oversees the completion of product baseline information for projects assigned including lab testing results and qualification test plans, manufacturing or distribution reviews, product design specifications, and adherence to product development timelines.

• Works with cross functional work teams to complete projects ensuring all parties are apprised throughout the stage gate process of assigned projects.

• Support daily QA/QC activities as required to meet company needs.

• Maintain records and samples in an organized manner to allow ease of retrieval.

• All employees have the responsibility and authority to report any action that puts any process or product at risk.

• Other duties as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty / key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Must have a degree or technical certificate in Chemistry, Engineering, or other technical area.

Experience:

Must have 3 years previous QA experience in an analytical testing or laboratory environment.

Skills & Abilities:

Must be able to read, write, and speak English. Provides leadership and support for subordinates by encouraging independent thought and action as well as encouraging interaction with other departments. Must be proficient in Microsoft Word, Excel, and Access. Must be able to demonstrate ability to prioritize and organize multiple functions; flexible and detail-oriented. Must possess initiative, common sense, and analytical/problem-solving characteristics. Must be able to work independently and capable of working well with others. Must have the ability to communicate and supervise professional/technical staff. Position is responsible and qualified to train. Must be able to demonstrate complete understanding of their position job functions and subordinate positions, able to carry out training as required.

Health, Safety & Environmental Considerations/Requirements:

Must be able to carry out all of the essential functions of the position in a safe and responsible manner including taking precautionary measures to protect his or her own safety and health, the safety and health of others in addition to protecting the environment. Always uses and maintains appropriate personal protective equipment (PPE) - protective clothing, equipment, and other health and safety facilities provided for the protection of his or her health and the safety of others. Reports immediately to his or her supervisor any situation, which he or she believes, presents a risk to his or her health or safety or that of any other person and or that of the environment. Abides by and cooperates with management, employees and others to ensure compliance with Health, Safety, and Environmental policies and procedures. Conducts inspections of health, safety and environmental conditions and risks in his or her working area as required, corrects sub-standard items/conditions/risks and/or reports these to his or her supervisor as appropriate. Asks questions and/or informs his or her supervisor when unsure about any health, safety or environment condition, policy or procedure.

Everyone has the responsibility and is empowered to take personal leadership to:

▪ Ensure personal compliance to meet all EHS standards

▪ Take immediate action to correct any substandard condition or behaviors

▪ Ensure work areas and equipment are in safe condition.

▪ Ensure that every task/job performed is done safely and with no adverse health consequences.

▪ Identify, assess, control and report hazards using Field Level Risk Assessment.

▪ Safeguard and watch out for co-workers.

▪ Identify new workers and help coach them to learn proper work activities.

▪ Follow established procedures.

▪ Identify and communicate situations where procedures are not adequate or do not exist.

▪ Ask for help if skills, physical capabilities and/or knowledge are not adequate to do the tasks.

▪ Refuse work deemed unsafe and report to your supervisor.

 

STOP and THINK

▪ Stop frequently to analyze.

▪ Think continuously to anticipate and especially every time something changes.

IDENTIFY THE HAZARD

▪ Ask what could go wrong and anticipate all the possibilities.

ASSESS THE RISKS

▪ Ask how bad it could be

▪ Ask could I be hurt?

▪ Ask could others be hurt?

CONTROL THE RISKS

▪ Ask what I could do about it

▪ Take action by changing position, method or get help

▪ Report it to my supervisor

RESUME WORK

Job Description Acknowledgement

ASO LLC and all affiliated companies (“ASO”) continuously reviews its job descriptions in an effort to

keep employees informed of their overall job responsibilities. However, your job description is not all inclusive. You may be asked to carry out job responsibilities and/or functions that are not noted on the job description.

The receipt of a job description is not intended to create a contract for a specific term of employment and/or any other legally enforceable promise, and that continued employment with ASO or all Affiliated companies (“ASO”) is at will.

By signing each page, the signature of the employee acknowledges the receipt of this job description.

By signing each page, the signature of the manager acknowledged reviewing the job description with the employee.

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