Sr. Quality Assurance Specialist - 2nd Shift

Alcami; New Cumberland (Cumberland County); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Quality Assurance Specialist to ensure compliance and quality in a dynamic environment. This role involves reviewing documents, conducting audits, and mentoring team members to foster a culture of quality. The ideal candidate will have extensive GMP experience and a strong background in quality assurance. Join a dedicated team committed to excellence in transformative medicine and make a significant impact in an organization that values innovation and quality.

Qualifications

• 10+ years of GMP related experience in a quality assurance role.
• Experience in developing SOPs and conducting audits.

Responsibilities

• Perform quality review and approval of documents and data.
• Conduct internal quality audits and maintain quality databases.

Skills

Aseptic parenteral manufacturing

GMP and Annex 1 experience

Visual acuity

Education

Bachelor’s degree in Chemistry, Biology, or related field

Master’s degree in related field

Job description

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.

Are you interested in joining our team?

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, Executed Batch Record review & release, 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

• 100% on-site position.
• 2nd Shift: Monday - Friday, 3:00pm - 11:30pm.

Responsibilities

• Performs quality review and approval of documents, data, protocols, and/or reports.
• Master Batch Record review & Executed Batch Record review & release
• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).
• Performs visual inspection of parenteral product (requires qualification).
• Performs internal quality audits and/or inspections.
• Supports client audits and inspections, and regulatory inspections.
• Maintains quality databases.
• Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness.
• Assists with quality improvement initiatives as needed.
• Consults with clients on production and documentation.
• 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.
• Grade C gowning.
• GMP and Annex 1 experience.
• Visual acuity.

Travel Expectations

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

Physical Demands and Work Environment

• 20/20 corrected vision for Visual Inspector qualification.
• Grade C gowning training.