Quality Associate II

Operations Services Waynesville, North Carolina


Description

The primary responsibility of this position is to provide Quality Assurance and Quality Control activities to support Production. This role will also ensure compliance with all applicable regulatory mandates and/or customer specific requirements. Conduct audits, inspections, and investigations of routine to moderate complexity at various stages of production. Responsible for assisting with investigations into events involving non-conforming raw materials, finished product or goods, and deviations.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES
May conduct various Quality audits and inspections.
  • In-process
  • Line audits
  • Start-ups and changeovers
  • Finished Goods
  • Trailers
  • Incoming raw materials.
  • GMP Audits
  • Conduct initial research into nonconformances and process deviations as directed.
  • Maintain cGMP compliant documentation of Production and Quality records.
  • Maintain Chemical Inventory Management documentation and records.
  • Maintain Incoming Raw Material documentation and records.
  • Assist with Stability, Reserve, and USP Sampling Programs.
  • Contribute to on-going review and update of written procedures and forms for alignment with current processes and draft their initial edits.
  • Collect and report observations of systemic improvement opportunities.
  • Review and approval for release of GDP and cGMP compliant Daily Batch Records and other Quality records.
  • Identify and place any non-comforming material or products on Quality Hold. This will include physical placarding, quarantining and system Quality Holds.
  • Assist with product returns and make appropriate notifications.
  • Maintain cleanliness and organization of all Quality areas.
  • Maintain Quality Hold Logs and the Disposition of products.
  • Intermediate Data Entry (Logbooks, Spreadsheets, and ERP system)
  • Assist Supervisor with maintaining Daily Compliance Logs.
  • Will coordinate with training staff to educate employees on Good Manufacturing Practices, Good Documentation Practices, and Safety & Housekeeping Policies. Assist Production Supervisors and the Training Dept. with employee training.
  • Maintain and organize Document/Record Storage.
  • Train QA1 and other Quality Staff as needed.
  • Report observations of unsafe working conditions to management.
EDUCATION and/or EXPERIENCE
Minimum Education Details:
  • High school diploma or GED
  • Functionally capable in Microsoft Word, Sharepoint/Teams, and Excel.
  • QA/QC experience in regulated environment required.

A member of the S&P 500 Index, Martin Marietta is an American-based company and a leading supplier of heavy building materials – including aggregates, cement, ready-mixed concrete and asphalt. Through a network of operations spanning 28 states, Canada and the Bahamas, dedicated Martin Marietta teams supply the foundational resources upon which our communities thrive. Martin Marietta's Magnesia Specialties business produces high-purity magnesia and dolomitic lime products used worldwide in environmental, industrial, agricultural and specialty applications.

At Martin Marietta, we strive to work with the best and the brightest – those who have the potential to become our company's future leaders. Each of our roughly 9,500 people shares a common purpose regardless of their professional role or work environment. Together, we utilize our diverse skills and experiences to drive our company and its extraordinary culture forward. Our aim is to build on our foundation of success and help values-driven and hardworking people realize their full potential. When you decide to invest your career in Martin Marietta, you'll know what it's like to be respected, challenged and rewarded.

In return, we offer a highly competitive benefits package, including: 

  • Medical
  • Prescription Drug
  • Dental
  • Vision
  • Health Care Reimbursement Account
  • Dependent Care Reimbursement Account
  • Wellness Programs
  • Employee Assistance Plan
  • Paid Holidays and Vacation
  • 401(k) with Company matching
  • Pension
  • Salary Continuation – Short-Term Disability
  • Long-Term Disability Options
  • Employee Life Insurance
  • Spouse & Dependent Life Insurance
  • Business Travel Accident Insurance
  • Direct Deposit Payroll
  • Educational/Tuition Assistance Plan
  • College Scholarship Program – for dependent children
  • Matching Gift Program
  • New Auto Purchase Discount Plans

At Martin Marietta, we are proud to be an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all qualified applicants and teammates. We celebrate diversity and commit that qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.