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.
Job Type: Full-time
Pay: $18.00 - $20.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- QA/QC: 2 years (Required)
- Quality Assurance: 2 years (Required)
Ability to Relocate:
- Easthampton, MA 01027: Relocate before starting work (Required)
Work Location: In person