Title: Quality Specialist Location: Dover, DE (fully onsite Monday - Friday) Duration: 12-Month contract Pay Range: $25-$30/hr Description: This position will perform work that is crucial to the control, security, and integrity of documents and data that is used in the review and release of products. Under direct supervision, this position is responsible for conducting routine tasks within the Quality Assurance program comprised of data review and confirmation of results against known standards.
- Accountabilities
- Reviews and approves device history records in support of final product release.
- Issues nonconformance related to documents and products.
- Generates certificates of analysis for products when applicable
- Communicates information and results to the Quality Supervisors and to the applicable departments.
- Ensures data collected during testing and manufacturing are accurate and complete.
- Performs database and document-control functions.
- Promotes and exercises good documentation practices on hard copy and electronic records.
- Communicates any unexplained discrepancies or deviations to Supervisor or applicable departments to ensure proper investigation is conducted and documented.
- Promotes and adheres to document 3-year review policy.
- Performs records management and record retention activities for documents and quality standards.
- Aids in development and training of procedures.
- Monitor trends and report quality metrics to Quality Supervisor
- Monitor and track product and process nonconformances.
- Monitor and track failure investigations.
- Support Operations team with issues impacting quality and shipping performance.
- Provide guidance in interpreting quality characteristics and defect categories
- Ability to write, review and revise SOPs, product specifications, Bill of Materials, and packaging assembly specs.
- Ability to review and approve nonconformance reports
Required Education, Skills and Experience
- Requires a diploma and 5 years of experience or Bachelors and less than 1 year of experience in Manufacturing environment.
- 3-5 years proven track record in the use of databases or electronic systems.
- Extremely organized and detail oriented, Being able to work in Fast-Paced position
- Excellent communication skills, written and verbal.
- Excellent Computer Skill
- Knowledge of GMPs. Standards, and regulations
- Desirable Education, Skills and Experience
- ASQ Certifications such as CQIA a plus.
- 3-5 years' experience in a regulated business.
- Working knowledge of regulated industry standards such as 21 CFR Part 820, 21 CFR Part 11, ISO 13485, etc
- Environmental, Health and Safety Responsibilities (if applicable)
- Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
- Perform every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities. This includes the use of required personal protective equipment and use of safety equipment as well as safe work practices.
- Immediately report every job-related injury or illness, regardless of severity, to a supervisor.
- Assist in investigating incidents as directed by your supervisor.
- Take necessary actions to correct or stop any unsafe conditions or practices.
- Actively participate in safety meetings and training.
- Review Material Data Sheet instructions before working with any chemical product.
- Quality Assurance Responsibilities (If applicable)
- Colleagues are responsible for their own quality and that of colleagues within their span of control.
- Colleagues are responsible to follow all established Quality procedures and instructions.
- Notify supervision for corrective action if and when defects are found and/or parts/processes do not conform to specifications.
EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-###-####.Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.