Job Details
Job Title: QC technician
Location: 100% Onsite in Dover DE
Duration: 6M+ Contract
Pay Range: $15-18/hr
If interested in applying for this opportunity, please send a copy of your updated resume toRonak Gandhi @ [email protected]
Position Summary
Work in a cGMP laboratory performing sampling and testing of incoming raw materials and components. Work on routine and non-routine laboratory projects as directed by Quality Laboratory Management.
Universal Accountabilities
- Perform sampling and testing for raw materials, components, and special projects using a variety of measurement techniques.
- Follow cGMP and 21CFR 820 requirements for laboratory testing and investigations.
- Collaborate with internal and cross functional colleagues to assure inspections are completed on time.
- Manage material flow in conjunction with Planning and Scheduling.
- Follow SOPs and test methods.
- Maintain 5S standards in the lab.
- Must display accuracy and attention to detail while completing inspections and documenting results with minimal errors.
- Support laboratory supervisor in OOS investigations. Compiles data and participates in different steps of the investigation process.
- Must be willing to work overtime as needed.
- Work on non-routine projects as directed by the laboratory supervisor.
Specific Accountabilities - Perform job duties in a compliant and safe manner.
- Adhere to testing and projects deadlines as assigned by quality laboratory management.
- Adhere to 5S standards in the laboratory.
- Escalates non-conformances and Out of Specification results in a timely manner and in accordance with local and corporate procedures.
- Keep up with laboratory productivity standards.
- Adhere to the designated work schedule.
Required Skills and Experience - Associate's degree or high school diploma, or equivalent experience.
- Must be able to work with minimum supervision.
- Effective verbal / written communication, interpersonal, and team-building skills.
- Excellent organizational, problem-solving, prioritizing and follow-up skills.
- Ability to handle multiple tasks / projects simultaneously.
- Good computer skills. Proficiency with Microsoft Word, Excel, Power Point and other computer software as needed.
Preferred Skills and Experience - Experience working in an FDA regulated laboratory.
- Working knowledge of SAP.
- Working knowledge of FDA 21 CFR part 820, 210 and 211 requirements.
- Working knowledge of Canadian Medical Device Regulations SOR/98-282
- Working knowledge of ISO 13485 and 14971 requirements
- Experience working in cGMP laboratory
Working Relationships - Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, Safety and other technical support groups)
- External contacts: Suppliers and Service Providers as needed or as directed by laboratory management.
Work Environment - Be aware of and follow the Environmental Policy and EHS work instructions/procedures that apply to the job.
- Work schedules that vary from typical business hours.
- Exposure to health risks or conditions that may require the use of Personal Protective Equipment.
- Ability to work in a non-climate controlled Warehouse environment for periods of time.
Environmental, Health and Safety Responsibilities - Conform to safety regulations and procedures to maintain a safe working environment.
- Be aware of and follow the Environmental Policy and EHS work instructions/procedures that apply to the job.
- Performing every job safely, for the benefit of self, co-workers, contractors, and for the protection of the facility. This includes the use of required personal protective equipment and use of safety equipment/devices, guarding, as well as safe work practices.
- Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
- Assist in investigating incidents.
- Taking necessary actions to correct or stop unsafe conditions or practices.
- Actively participation in safety meeting and training.
- Review SDS instructions before working with any chemicals or hazardous materials.
Quality Responsibilities - 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.
- Colleagues are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
- Colleagues are responsible for adhering to current Good Manufacturing Practices (cGMP) work rules as they relate to job-specific duties.
Supplemental Information - This description is based on management's assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job. Management reserves the right to modify and description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet the production, scheduling, or staffing needs.
EEO Employer
Apex 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.