“Be part of a rapidly growing company in the Pharma/Biotech industry!”
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.
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
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.
About Overlook Industries, Inc.:
Overlook Industries specializes in single-use fluid path technology for the Pharmaceutical and Biotechnology industry. Whether it's single-use liquid filling needles designed to replace all OEM needle designs or complete liquid filling assemblies, Overlook works with companies to meet their needs.