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Compensation

$20 to $26 Hourly

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

Why Work Here?

“Be part of a rapidly growing company in the Pharma/Biotech industry!”

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.

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.

Company address: 193 Northampton Street

Posted date: 25 days ago

View all Jobs at Overlook Industries, Inc.