• Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager.
• Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities.
• Support the implementation of regulatory changes and quality system improvements as directed;
• Assist in preparing responses to audit observations or regulatory findings that involve document or records management.

This job also requires performing other duties as assigned.

• Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field.
• 0-3 years of experience in a regulated industry (pharmaceutical or biotech).
• Knowledge of GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820).
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Knowledge of ALCOA+ data integrity principles.

• Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile, TrackWise) even if primary system is paper-based.
• Experience with EU GMP, ICH Q7, ICH Q2(R1), and/or ISO 13485 requirements.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Attention to detail and commitment to data integrity and accuracy in all quality records.
• Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations.
• Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously.
• Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions.
• Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements.
• Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items.
• Aptitude for learning and applying regulatory requirements and quality standards.

• Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
• Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position requires the individual to meet multiple demands from several people and interact with internal and external people;
• Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
• Employee may have duties involving walking on even or uneven surfaces;
• Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
• Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
• It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently;
• Employee must see and hear on a continuous basis as well as speak frequently;
• Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

ProMed offers a generous benefits package including:

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.