QA Lab Technician

Strukmyer Medical, a leading medical device contract manufacturing company, is seeking a detail-oriented and skilled Quality Lab Technician to join our dynamic team. As a Quality Lab Technician, you will play a crucial role in ensuring the highest standards of quality and safety for our medical products.

Responsibilities:

· Perform a wide range of analytical tests on raw materials, in-process samples, and finished products using various laboratory equipment.

· Conduct routine and non-routine analysis using techniques such as HPLC (High-Performance Liquid Chromatography) and other appropriate methods.

· Document and maintain accurate records of all test results, ensuring compliance with regulatory requirements and internal quality standards.

· Identify and report any deviations or non-conformities and collaborate with a cross-functional team to investigate and resolve issues.

· Participate in the calibration, maintenance, and troubleshooting of laboratory equipment to ensure reliable and accurate test results.

· Assist in the development and validation of analytical test methods, ensuring their suitability for quality control purposes.

· Collaborate with cross-functional teams to support investigations, root cause analysis, and corrective actions related to quality issues.

· Contribute to continuous improvement initiatives by actively participating in process optimization and efficiency enhancement projects.

· Adhere to safety protocols, good laboratory practices (GLP), and standard operating procedures (SOPs) at all times.

· Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews and Stability Studies for applicable products manufactured on site.

Requirements:

· Bachelor's degree in Chemistry, Biochemistry, or a related field is preferred. Candidates with relevant laboratory experience will also be considered.

· Proven experience in performing analytical testing in a laboratory setting, including hands-on experience with HPLC (High-Performance Liquid Chromatography).

· Familiarity with other analytical techniques such as FTIR spectroscopy, and wet chemistry methods is a plus.

· Strong attention to detail and excellent organizational skills to ensure accurate documentation and recording of test results.

· Knowledge of quality control principles, laboratory safety protocols, and regulatory requirements (e.g., FDA, ISO) applicable to the medical device industry.

· Ability to troubleshoot and maintain laboratory equipment, ensuring their optimal performance.

· Proficient in using laboratory software and data analysis tools to process and interpret test results.

· Effective communication skills to collaborate with cross-functional teams and present findings and recommendations clearly and concisely.

Physical/Mental Requirements:

Must be able to work effectively under pressure and meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Job Type: Full-time

Pay: From $15.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Education:

• Bachelor's (Preferred)

Experience:

• Laboratory: 1 year (Preferred)

Language:

• English (Required)

Work Location: In person

Salary : $15 - $-1