Quality Control Specialist

The Quality Control Specialist is responsible for all tasks in support of Customer Service and Distribution Operations. Collaboration with Quality Assurance, Fields Services, Logistics, and other internal departments, to develop and implement strategies, objectives, and policies and procedures to fulfill the companys annual Management by Objective (MBO) decisions. Support Company goals and objectives, Policies & Procedures, Quality System and FDA Regulations.

Essential Functions:

• Develop QC documentation, such but not limited to, Standard Operating Procedures, guidance documents and records.
• Recommend and assist implementation of new procedures and processes to improve existing procedures. Update current departmental procedures as needed.
• Assist transfer of QC assays from R&D to Operations, complete with all relevant documentation.
• Ability to effectively/expertly perform in-coming QC inspections, in-process and final QC of semi-finished and finishes.
• Analyze all QC data and troubleshoot QC non-conformances.
• Manage equipment calibration/ maintenance records.
• Ensure proper organization and maintenance of all cold and room temperature storage areas.
• Troubleshoot customer complaints and non-conformance.
• Develop and utilize process for Returns Goods.
• Support Quality Assurance team to manage documentation.
• Support Quality Assurance team to establish and execute supplier qualification.
• Support Production with trainings and development of records including Batch Records and other production activities, such as but not limited to, troubleshooting, support product transfer to manufacturing.
• Complete formal annual performance reviews, and as needed, informal performance reviews as required.
• Other duties as assigned by Management.

Education & Experience:

• Bachelors Degree required
• At least one year of experience in production/manufacturing in a biotechnology company required
• Quality Control experience preferred

Competencies:

• Excellent computer skills including Microsoft Word, Excel, and PowerPoint.
• Demonstrates independent judgement in resolving problems and making recommendations.
• Must be able to write clear, understandable documentation with effective presentation of information.
• Ability to work in a high-pressure, customer-focused environment.
• Attention to detail and good organizational skills.
• Excellent verbal and written communication skills.
• Ability to understand documentation and effectively present information.
• Work autonomously to meet project deadlines.

Physical Demands:

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. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear.

Heavy work. Exerting up to 100 pounds of force occasionally while partnering to lift, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects. Frequently required to stand for long periods of time in the warehouse, walk, stoop, kneel, and bend. Occasionally required to sit and climb or balance. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus.

Schedule:

• Monday-Friday 8:00am-5:00pm

Benefits:

• 401(k)
• 401(k) matching
• Health Insurance
• Dental Insurance
• Vision Insurance
• Flexible spending account
• HSA
• Paid Time Off