At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling quality culture.

On-Site Expectations

• Hybrid role with 3 days per week expected on-site.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Provide regulatory expertise and strategy for clients on their products and services.
• Performs quality/regulatory review and approval of documents, data, protocols, and/or reports.
• Performs negotiations for new quality agreements.
• Represents regulatory in intracompany meetings and client meetings.
• Maintains licenses and current registrations.
• Supports internal quality audits and/or inspections.
• Supports client audits and inspections, and regulatory inspections and responses.
• Maintains regulatory databases.
• Assists with implementation and supports quality systems, including but not limited to, operations support, training, vendor management, and overall regulatory inspectional readiness.
• Assists with quality improvement initiatives as needed.
• Assists with development of SOPs or other quality documents.
• Maintains accurate files and records.
• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.
• Complies with company polices and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master's degree in related field.
• Minimum five years of related work experience.

Knowledge, Skills, and Abilities

• Aseptic parenteral manufacturing or oral solid dosage form manufacturing.
• GMP and Annex 1 experience.
• Good writing and communication skills.
• Proficient in regulatory submissions (IND, ANDA, NDA, BLA, NADA).

Travel Expectations

• Rarely may be requested to travel to support other Alcami sites.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.