Quality Analyst

Quality Compliance Specialist (Level I / Level II)

Location: Salisbury, MD

Position Type: Full-Time

Travel Requirements: ~10% Domestic, occasional International

Position Summary

We are seeking a dedicated Quality Compliance Specialist to support quality compliance systems and objectives at our Salisbury, MD site. In this role, you will maintain a quality mindset, drive continuous improvement, and implement quality initiatives in accordance with industry and regulatory requirements. You will collaborate closely with cross-functional teams, including Quality Control, Production, and Regulatory Affairs.

Key Responsibilities

Quality Oversight & Compliance Management

• Provide quality and compliance oversight for manufacturing and warehouse activities, including on-the-floor support to assess deviations and incidents.

• Support the release of finished goods documentation, including technical reviews of batch records, labeling, Certificates of Analysis (COA), reprocessing instructions, and lot deviations.

• Facilitate and implement Corrective and Preventive Action (CAPA) plans.

• Coordinate and investigate customer complaints.

• Maintain and monitor compliance tracking systems and archive records (e.g., document control, deviation reporting, calibration, records retention/destruction).

• Assist in developing and editing Standard Operating Procedures (SOPs), forms, flow diagrams, and specifications.

Auditing & Regulatory Support

• Prepare the site for FDA, USDA, and other regulatory compliance audits; assist in developing remediation plans and regulatory responses as needed.

• Conduct internal compliance, surveillance, and focused audits (audit plan development, technical documentation review, risk identification, and final reporting).

• Perform vendor and supplier quality audits to ensure incoming material and service quality.

• Provide Regulatory Affairs compliance support for submissions, approvals, product labeling, and registrations.

• Interpret and communicate regulatory requirements (cGMP, CFR, etc.) as they relate to company products and operations.

Training & Continuous Improvement

• Educate and mentor employees on quality system requirements, compliance expectations, and cGMP standards.

• Develop training modules and conduct new hire, cGMP, and refresher training courses.

• Continuously drive internal process and product improvements with a strong quality mindset.

Technical & Engineering Reviews

• Perform technical reviews and approvals for validation documents, design reviews, engineering reviews, IQ/OQ/PQ, protocols, and project reports.

• Provide compliance guidance for new/existing processes, facilities construction, installation, and design reviews.

Qualifications & Experience Requirements

Level I Requirements:

• Education: BS degree in a scientific field preferred.

• Experience: Minimum of 2 years of related experience, preferably in an FDA-regulated industry.

• Knowledge: Fundamental understanding of cGMP regulations and global regulatory standards.

• Skills: Strong written and oral communication skills; ability to work independently.

• Travel: Willingness to travel (~10% domestic, occasional international).

Level II Requirements:

In addition to Level I requirements:

• Experience: Minimum of 5 years of related experience in an FDA-regulated industry.

• Track Record: Demonstrated success interacting with senior management, external audit groups, and regulatory bodies (e.g., FDA, USDA).

• International Experience: Familiarity with Canadian, EMEA, or Latin American regulatory regions desired.

• Certifications: Certified Quality Auditor (CQA) preferred.

Core Technical & Soft Skills

• Strong interpersonal skills with the ability to communicate effectively across all levels of the organization and with external vendors/customers.

• Exceptional attention to detail and strong time management skills.

• Creative problem-solving capabilities to accomplish tasks while balancing timelines and budget constraints.

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Pay Details: $26.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.