What are the responsibilities and job description for the QA Compliance Associate I-III position at AmbioPharm - A Global Peptide CDMO?
QA Compliance Associate I/II/III
This role is located at our office in North Augusta, SC. You MUST be willing to relocate to the area, we do provide relocation assistance. If you are interested in learning more, apply now!
Primary Responsibilities
Associate level I:
This role is located at our office in North Augusta, SC. You MUST be willing to relocate to the area, we do provide relocation assistance. If you are interested in learning more, apply now!
Primary Responsibilities
- Ensure audits are conducted and maintained per audit schedules (i.e.- internal, vendor, customer, external, monthly).
- Generate and review daily, monthly, quarterly, and yearly quality metrics. Present metrics to site management.
- Generate and/or review annual product reviews (APRs), as required per SOP.
- Generate trend reports and other reports as requested.
- Monitor and support quality programs, policies, processes, procedures, and controls ensuring compliance. Generate vendor scorecard ratings.
- Monitor and control the supplier quality program (i.e. - ensure compliance with qualification of vendors, materials, services, etc.). Qualify new suppliers, test labs, raw materials as needed through on site and vendor audits. Generates improvements, as necessary.
- Remains informed about current good industry practices and suggests areas of improvement.
- Support, coordinate, and interface with customers and regulatory agencies as required in support of responses, regulatory agency inspections, and customer audits.
- Works cross-functionally to assess impact for potential deviations and assist in identifying if an investigation and corrective actions are required.
- Updates Standard Operating Procedures and any other documents as required.
- Initiate deviations for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
- Other assignments as needed to support the Quality department (management, compliance, documentation, operations, and analytical teams).
- Conduct monthly Quality walkthroughs
- Generate the annual monthly walkthrough schedule
- Enforcement of GMP Compliance.
- Promotes GMP, Teamwork and Safety within the company.
Associate level I:
- A Bachelor’s Degree is required. (Chemistry, Biology, or other Life Science degree is preferred) 2-5 years in a QA role. Learning systems and processes.
- A Bachelor’s Degree is required. (Chemistry, Biology, or other Life Science degree is preferred) 5-7 years in a QA role. Participating in audits (customer and vendor)
- A Bachelor’s Degree is required. (Chemistry, Biology, or other Life Science degree is preferred) 7 years plus in a QA role.
- Microsoft Office Suite proficiency is required.
- Team player with good communication skills, documentation, proficient reading, and comprehension skills.
- Able to work with limited supervision for routine tasks and demonstrate initiative and train others.
- Good time management skills and ability to work independently with little supervision to complete tasks.
- Ability to travel up to 25%.
- Excellent verbal and written communication.
- Experience with MasterControl is desired.
- In-depth knowledge of relevant regulations/standards, i.e., FDA 21CFR210/211, ICH Q7, FDA 21CFR1271, ISO9001
- Leading audits
- Must be able to push, pull, squat, stand and walk through-out the day with or without assistance.
- Must be able to lift up to 20lbs.
- You must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
- You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
- You must be able to work in a chemical environment.