Quality Associate

SUMMARY:

The Quality Associate is part of a diverse team responsible for implementation and maintenance of Overlook’s Quality System. The Quality Department controls a wide range of Overlook’s systems, including the Equipment, Documentation, Vendor and Training Programs.

DUTIES AND RESPONSIBILITIES:

• Review and approve forms related to routine activities such as incoming inspection of raw materials, facility cleaning and preventative maintenance of equipment.
• Reviews and approves Standard Operating Procedures (SOP).
• Reviews and approves quality events including non-conformances, change control and corrective/preventative actions.
• Maintains, organizes and archives documents including manufacturing packages, SOP’s and executed job records.
• Reviews and approves manufacturing packages used for production including blueprints, routing sheets, and inspection logs.
• Coordinates the initiation/revision of manufacturing packages with the engineering department.
• Releases manufacturing packages for production based on client purchase orders.
• Reviews and approves executed manufacturing packages to ensure the product was manufactured in accordance with blueprints and applicable SOP’s.
• Generates Certificates of Compliance (CofC), releases product labels and authorizes release of client product.
• Coordinates production and testing associated with quarterly dose audits per ISO 11137-2.
• Assists the Quality Assurance Manager with maintenance of the Quality System.
• Performs other related duties as assigned by management.

QUALIFICATIONS:

• Associate's Degree from two-year college in relevant field and 2-3 years prior Quality experience in cGMP or ISO 9001:2015 regulated company
• Bachelor's Degree (BS/BA) from four-year college or university in relevant field and 1-2 years prior Quality experience in cGMP or ISO 9001:2015 regulated company

COMPETENCIES:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Frequently required to stand and walk. Continually required to sit.
• Occasionally required to utilize hand and finger dexterity.
• Occasionally required to climb, balance, bend, stoop, kneel or crawl.
• Continually required to talk or hear.