Quality Control Specialist

DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:

• Responsible for Document Control and Records Retention.
• Trends data from Quality System inputs and creates monthly charts and reports.
• Assists in Quality Management Review preparation.
• Assists with Failure Investigations (Complaint, Non-Conformance, Supplier, etc.)
• Participates in internal audit program.
• Works with Quality and Operations management on short and long term quality planning and quality system improvements initiatives.
• Drafting new, and revising existing Standard Operating Procedures (SOP)
• Approval to ship conforming product following full review of process documentation.
• Make records of quality activities per specified procedures.
• Maintain all required documentation of work performed and ensure that all forms and materials are labeled properly.

BASIC QUALIFICATIONS:

• BS/BA Degree in a scientific/technical field and 2+ years working in a regulated environment.

OR

• AS Degree in a scientific/technical field and 4+ years working in a regulated environment.

PERFERRED QUALIFICATIONS:

• ASQ Certifications a plus.
• Working with Pharma or Medical Devices preferred
• Experience with ISO 13485 or ISO9001 preferred.
• Demonstrated ability to work effectively and positively with all levels of an organization.
• Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
• Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
• Strong organization skills required.

WORK ENVIRONMENT:

• Temperature controlled office and manufacturing environment with large printing and related equipment.

PHYSICAL REQUIREMENTS:

• Sitting, standing, walking, stooping, bending, squatting, leaning, climbing stairs and ability to lift 40 pounds.

COMPENSATION RANGE:
The annual base salary range for this full-time position is $55,000-70,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into