At Safecor Health, we are dedicated to improving patient safety and supporting hospital pharmacy operations nationwide. As the industry leader in pharmaceutical unit-dose packaging, we live our core values every day—Care for our people and customers, Commitment to doing what’s right, and a pursuit of Excellence in everything we do.
Position Summary
The
Consultant, Quality Operations plays a key role in supporting Safecor Health’s Quality Operations team. This position helps ensure compliance with FDA, DEA, and state regulations while contributing to the effectiveness of our Quality Systems and Quality Control processes. The ideal candidate will bring a strong commitment to quality, attention to detail, and a collaborative mindset aligned with Safecor’s values.
Key Responsibilities
Quality Control Operations
- Support and maintain FDA-compliant Quality Systems (21 CFR Parts 210 & 211).
- Perform Environmental Monitoring activities including sampling, testing, protocol development, coordination with laboratories, and reporting.
- Assist with Cleaning Validation programs including sampling, protocol development, investigations, and reporting.
- Participate in risk assessments related to equipment, materials, and validation processes.
- Monitor regulatory and compendial updates impacting operations.
- Support MVTR testing and laboratory supply management.
- Contribute to internal and external audit preparation and execution.
- Engage in special projects to improve Quality Operations.
Operational Quality Activities
Assist with sample retention, audits, and product destruction processes.Support USP testing and validation activities.Perform temperature and humidity monitoring and mapping studies.Coordinate sample shipments to external laboratories.Support maintenance and monitoring of Purified Water Systems across all facilities.
Documentation & Records
- Draft, review, and maintain SOPs, forms, and work instructions.
- Support change control and quality documentation systems.
- Assist in Annual Product Reviews (APRs).
- Provide data entry and review support in quality systems.
Issue Resolution & Continuous Improvement
- Document and track deviations, CAPAs, incidents, and OOS investigations.
- Monitor quality metrics and support trend analysis.
- Collaborate cross-functionally to implement corrective and preventive actions.
- Participate in continuous improvement initiatives to enhance compliance and efficiency.
Facilities & Equipment Oversight
- Support quality oversight of facility systems including temperature controls and water systems.
- Assist in maintaining equipment records and calibration schedules.
Qualifications
Education & Experience
- Bachelor’s degree in Chemistry, Life Sciences, or a related field (or equivalent experience).
- 3–5 years of experience in the pharmaceutical or related industry, with a focus on Quality Assurance/Quality Control.
- Experience in a Quality Control or Microbiological laboratory preferred.
- Working knowledge of FDA regulations and cGMP requirements required; DEA experience preferred.
- Familiarity with quality documentation systems and regulatory inspections is a plus.
Knowledge, Skills & Abilities
- Strong understanding of FDA expectations, ICH guidelines, and cGMP practices.
- Experience with laboratory instrumentation (e.g., HPLC, GC).
- Excellent organizational, documentation, and attention-to-detail skills.
- Strong written and verbal communication abilities.
- Ability to work independently and collaboratively in a team environment.
- Proficiency with Quality Management Systems; experience with MasterControl preferred.
- Willingness to travel (approximately 1–2 times per quarter) to Safecor sites in Columbus, OH and Woburn, MA.
Core Competencies (Safecor Values in Action)
- Safety First: Prioritizes patient safety and product quality in all activities.
- Accountability: Takes ownership of responsibilities and delivers on commitments.
- Integrity: Acts ethically and ensures compliance with all regulatory standards.
- Collaboration: Builds strong partnerships across departments to achieve shared goals.
- Continuous Improvement: Seeks opportunities to enhance processes, systems, and outcomes.
Why Join Safecor Health?
At Safecor Health, you’ll be part of a mission-driven organization that directly impacts patient safety nationwide. We offer a collaborative environment, opportunities for professional growth, and the chance to contribute to meaningful improvements in healthcare quality and compliance.
Benefits
- Clean and safe work environment
- Medical, dental and vision insurance
- Company-paid life insurance
- Health savings account
- Paid time off (PTO)
- Holiday pay
- Weekly pay
- 401k
- Opportunities for internal promotion
- Monthly employee appreciation meals
