Full Time Deerfield Beach FL

QA Engineer - QMS

We have an immediate opening for a QA Engineer at our Deerfield Beach, Florida headquarters.

Our company provides final assembly, labeling, and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill-finish capabilities. Scientists and Engineers work closely with our partners to continuously create and introduce innovative, patient-centric solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their partner company counterparts to develop and maintain program timelines in line with our partners’ strategic and business needs. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved and have one clear point of responsibility.

Job description:

The QA Engineer provides support to Quality and Operations Management to ensure Quality related business systems (QMS) such as NCR, OOS, CAPA, Complaints, Change Controls, etc. are effectively implemented, maintained and fit into the business model and are compliant with regulations.

General responsibilities:

  • Fully understands Quality Management Systems and interactions between them
  • Coordinates and compiles APR/PQRs Reports as needed.
  • Performs complaint investigations in collaboration with relevant departments as needed.
  • Reviews deviations from established procedures to ensure a thorough investigation was performed, root cause was identified and CAPA was initiated as required.
  • Performs verification activities to ensure identified actions were implemented and effective.
  • Ensures that all changes that potentially impact product quality are documented per procedure.
  • Reviews Change Controls to ensure changes are adequately documented and do not negatively impact product or processes.
  • Analyzes key quality metrics and facilitates quality meetings as needed.
  • Revises applicable department procedures for compliance and/or improvement purposes.
  • Performs internal quality audits as needed.
  • Assists with customer and regulatory inspections as needed.
  • Assesses existing situations and suggests improvements to increase quality and compliance throughout the facility.
  • Plans and leads projects to ensure their timely completion.
  • Other tasks as assigned.
  • Plans and leads projects to ensure their timely completion.
  • Other tasks as assigned.

Requirements:

  • BS in Engineering, Manufacturing/Industrial Technology or other technical related degree.
  • A minimum of 5-7 years of experience in Pharmaceutical / Biopharmaceutical and / or Medical Device based GMP manufacturing operations
  • Experience developing and revising production and quality procedures and work instructions.
  • Strong knowledge in GMPs and ISO13485
  • Ability to work independently
  • Ability to make solid decisions and take appropriate actions in a rapid paced, forward evolving environment.
  • Strong knowledge and proficiency in the use of Microsoft Office and in the use of process control tools (Excel, SPC, Process Capability, Process Control Plans and Minitab).
  • Able to effectively communicate and work with all Company functional areas; must be change agile.
  • Authorized to work in United States

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 use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; stoop, kneel or crouch.
  • Specific vision abilities required by this job include close vision, and the ability to adjust focus.

We have an excellent benefits package and offer a salary that is based on experience and accomplishments. If you possess the required experience and qualifications and want the challenge of growing with our company, then submit your resume in confidence to our Human Resources Department at RecruitUS@shl-group.com.