Quality Lab Technician

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 physical property testing on In-Process, Finished Goods and Raw Material samples using a variety of measuring techniques.
• Perform sampling for raw materials, components, and special projects.
• Follow cGMP, 21CFR 820 and ISO 13485:2016 requirements for laboratory testing and investigations.
• Collaborate with internal and cross functional colleagues to assure inspections are completed on time
• 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 participate 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.
• Escalate non-conformances and Out of Specification results in a timely manner and in accordance to local and corporate procedures.
• Keep up with laboratory productivity standards.
• Adhere to the designated work schedule.

Required Skills and Experience

• Bachelor’s degree or high school diploma with 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, and Power Point.
• Must be able to learn and work with computer software such as SAP, OGP, spreadsheets.
• Must be willing to occasionally work OT as needed.
• 0 to 1+ year of experience working in a cGMP laboratory

Preferred Skills and Experience

• Experience working in a 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

Working Relationships

• Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
• External contacts:  Suppliers as needed or directed by laboratory management.

Work Environment

• Be aware of and follow the Environmental Policy and EH&S 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.

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 EH&S 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 facilities.  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 participate in safety meeting and training.
• Review SDS instructions before working with any chemicals or hazardous materials.

Quality Responsibilities

• 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 any 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.

The salary range for this position is $40,000- $60,000. Actual base salary offered to a candidate may vary based upon factors including, but not limited to, relevant experience, time in role, base salary of internal peers, prior performance, business sector, and geographic location. In addition to base salary, the competitive compensation package may include, depending on the role, participation in an incentive program linked to performance