QA Engineer - QA
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.
QA Engineer provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates and updates procedures and ensures Batch Records comply with established policies and procedures.
- Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.
- Prepare CofC and CoAs.
- Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.
- Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.
- Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.
- Review and approve Qualification packages (User Requirements, Validation Plan, Protocols, Reports) for Facilities, Utilities, and Equipment qualification activities.
- Review and approve Test Method Development, Validation and Stability Studies protocols and reports in support of the Analytical Sciences department.
- Support the investigation process for Non-Conformance’s and ensures completion of related corrective and preventive actions.
- Support the Audit Team with during external and internal audits.
- Provides support to the program management office with the review and approval of the design transfer package documentation.
- Provides Quality support for throughout the product life-cycle to include the review and approval of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives. quality and compliance throughout the facility.
- BS in Engineering, Biology, or other technical related degree.
- A minimum of 5-7 years of experience in Pharmaceutical / Biopharmaceutical and / or Medical Device based GMP manufacturing operations.
- Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
- Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
- Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility.
- Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations.
- Knowledge of Good Manufacturing Practices & Good Documentation Practices.
- Able to communicate effectively and work within cross-functional teams.
- Excellent oral and written communication skills with strong technical writing experience required.
- Experience in internal / external audits, identify findings, drive resolution and provide closure report
- Proficient skills in solving complex problems and ability to bring issues to resolution.
- Experience working globally with diverse teams and cultures.
- Must be able to successfully pass a pre-employment drug and background check.
- 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.