QA Analyst (2nd Shift

QA Analyst (2nd Shift)

The QA Analyst (2nd Shift) ensures product and process quality within a GMP manufacturing environment by auditing facilities and production lines, reviewing batch records, evaluating raw materials, bulk, and finished products, and driving continuous improvement. This role serves as a key quality resource on the manufacturing floor, supporting world-class manufacturing controls, regulatory compliance, and a strong culture of quality and lean practices.

Responsibilities

• Review production batch records to maintain a world-class manufacturing control program with a focus on training and first-time-right execution.
• Ensure documentation records are accurate and fully compliant with Good Documentation Practices (GDP).
• Verify compliance with current Standard Operating Procedures (SOPs), Work Instructions, and test procedures across the production environment.
• Train manufacturing personnel to improve compliance with regulatory and quality requirements and provide ongoing technical and process direction.
• Use strong interpersonal skills to help create and sustain a culture of quality and increase quality awareness throughout the facility.
• Document and investigate deviations and out-of-specification (OOS) situations, including root cause analysis and recommended corrective actions.
• Proactively update SOPs, Work Instructions, controlled forms, and test methods to support continuous improvement and regulatory compliance.
• Ensure product quality specifications and customer standards are consistently met and maintained to customer satisfaction.
• Complete approvals to run as needed and ensure quality events, such as deviations and non-conformances, are properly documented and escalated for timely decision-making.
• Confirm that products meet all specifications prior to release and ensure current reference and product standards are properly maintained.
• Update product specifications as needed in response to customer, process, or regulatory changes.
• Accurately record data and pertinent information in compliance with cGMP requirements.
• Use data to identify and resolve ongoing quality issues on the manufacturing floor, implementing permanent corrective actions.
• Document OOS situations, determine root causes, and suggest solutions to prevent recurrence of issues.
• Maintain compliance with current regulatory expectations and practices, including USP and FDA-related guidelines.
• Understand, promote, and maintain a culture of lean action within the department, focusing on waste elimination and process efficiency.
• Implement and maintain standards and processes that eliminate waste throughout the department.
• Apply lean tools to implement permanent improvements and institutionalize 5S (Sort, Straighten, Shine, Standardize, Sustain) in all aspects of the department.
• Spend the majority of time on the manufacturing floor ensuring equipment runs efficiently and verifying that the area is properly cleaned and maintained.
• Inspect bottles, labels, caps, production equipment cleanliness, and finished packaging, identifying defects and quality concerns.
• Serve as the primary quality resource on the production floor and in the warehouse, ensuring adherence to quality standards.
• Interact with production, warehouse, and other team members to determine quality needs, communicate issues, provide training, and deliver feedback.
• Work at a desk when not on the floor to review batch records, write protocols, and assist with investigations.
• Send professional emails in English to communicate quality issues, decisions, and updates to stakeholders.
• Enforce quality policies when needed, using sound judgment and confident communication.

Essential Skills

• Bachelor's degree in Chemistry, Biology, or a related scientific field.
• 1–2 years of experience in a GMP manufacturing environment such as pharmaceuticals, medical device, cosmetics, or food manufacturing.
• Experience reviewing batch records and/or compounding records.
• Hands-on experience working in a GMP environment with a strong understanding of cGMP principles.
• Practical knowledge of quality assurance in manufacturing industries, including pharmaceuticals, medical device, cosmetics, and/or food.
• Experience with CAPA (Corrective and Preventive Actions) processes and quality investigations.
• Familiarity with FDA-regulated environments and associated quality requirements.
• Ability to audit facilities, production lines, and documentation for compliance and quality standards.
• Strong attention to detail and consistency, especially in a fast-paced environment.
• Ability to stand and walk for 80–90% of the workday while performing inspections and floor-based quality activities.
• Ability to communicate clearly and professionally in written and spoken English.
• High level of integrity and sound judgment when enforcing policies and making quality decisions.
• Self-motivated with the ability to work independently while collaborating effectively with cross-functional teams.

Additional Skills & Qualifications

• Working knowledge of drug manufacturing…