Role Overview & Specifications

Job Description

Pay ranges between: $20-23/hr based on

experience

Perform a wide variety of activities to support the Quality Management System.

Essential

Duties And

Responsibilities

Conduct product testing, including testing to support complaint investigations and stability verification Generate product testing results reports Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval. Conduct spot-check inspections/audits of production operations Participate in the internal audit program Write, review and approve Standard Operating Procedures (SOPs) as necessary May assist in supporting the Document Control program, record retention areas, and sample retention areas May support returned instrument processing Log returned instruments from the field. Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required. Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing. As necessary, process instrument documentation for return to repair facility, and pack instruments as required.

Other

duties as assigned by supervisor

Supervisory

Responsibilities This Job Has No Supervisory

responsibilities.

Qualifications

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

Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)

Education And/or

Experience

Bachelor's degree in a scientific or technical area or equivalent combination of

experience and

education. At least one year in quality assurance role in medical device industry is preferred.

Language

Skills

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization.

Mathematical

Skills

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Computer

Skills

To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.

Certificates, Licenses, Registrations - None

Other

Skills and Abilities: Ability to follow procedures and accurately document results Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures Attention to detail. Ability to use bleach for cleaning purposes is required.

Physical Demands: 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 stand. The employee is occasionally required to walk.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the

essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the

essential functions.

The noise level in the work environment is usually quiet.

The Planet Group Of Companies Is An

equal opportunity employer. We celebrate

diversity and are committed to creating an inclusive environment for all employees.

Partner Recommendation

About Planet Pharma

Planet Pharma is an actively verified employer hiring talent across technology, engineering, and operations.

  • Headquarters: United States / United Kingdom
  • Company Size: 1,000+ employees
  • Trust Rating: 95 / 100 (Official Registry Audited)

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