Quality Control Reviewer

Description for Quality Control Lab Reviewer:

This position is self-directed and is responsible for performing quality assurance tasks and activities with minimal guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within Quality Assurance field. Relies on personal experience and judgment to perform primary job responsibilities.

Scope for Quality Control Lab Reviewer:

This is an independent contributor role. There are no direct reports for this position. Interaction is generally with laboratory and Quality Assurance personnel. This position reports to the QC Lab Supervisor/Manager.

Responsibilities for Quality Control Lab Reviewer:

• Performs basic clerical duties as required to ensure compliance to ISO 13485 and 21 CFR part 820.
• Seeks resolution to issues encountered during the course of routine quality duties.
• Responsible for QC document management and maintenance functions.
• Performs the first review of QC paperwork for completeness, accuracy, legibility, traceability to operator and equipment, and compliance to established specifications.
• Works with the QC Lab Supervisor and QC Technicians to rectify documentation errors in a timely manner.
• Prioritizes QC paperwork for review based on production and shipment schedules
• Works with Quality Engineers, QA, for scheduling and issues that arise from the QA review process
• Assists in investigations for deviations or Out of Specification (OOS) events as directed by QC Supervisor
• Makes suggestions for improvements to current documentation processes and systems.
• May be crossed trained for reviewing other quality documentation within the company.
• Performs other duties as assigned.

Education/Experience Requirements

• Education: High School diploma or GED, plus document control experience in a FDA regulated environment.
• Years of Experience: At least one year experience in analytical QC laboratory, in a FDA regulated, GMP environment.

Preferred Qualifications

• Preferred Education: Associates or Bachelors degree

Desirable Characteristics:

• Experience in a QC laboratory for full understanding of testing, GDP, ISO standards and sampling statistics
• Ability to read results to determine whether or not a testing error occurred
• Must be detail-oriented and accurate, with the ability to think proactively
• Ability to deal effectively with time pressures, stress, and changing demands of the job on a regular basis
• Strong math skills and ability to perform calculations for data review
• Ability to interface well with database systems
• Reasonable understanding of statistics
• Strong Good Documentation Practices (GDP) skills
• Ability to handle highly confidential information

Physical Requirements

Requires walking, ability to climb stairs, stoop, kneel, and reach above shoulder heights and below waist throughout the day. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required.

Working Conditions at Poly-Med, Inc.:

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Job Type: Full-time

Pay: $18.00 - $23.00 per hour

Expected hours: 40 – 42 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 5x8
• 8 hour shift
• Day shift
• Monday to Friday

Education:

• High school or equivalent (Required)

Experience:

• Laboratory techniques: 1 year (Required)
• Quality control: 1 year (Required)
• ISO 13485: 1 year (Preferred)
• Documentation review: 1 year (Required)

Work Location: In person

Salary : $18 - $23