QC Lab Analyst

Role Summary

The responsibilities of this position include performing routine quality control testing of a biologic drug substance, its intermediates, and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. The duties include environmental monitoring, organism identification, in-process release testing, water sample collection and other routine laboratory work. The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques. High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position. Must demonstrate flexibility/agility and engagement in a changing environment. The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples. Able to comprehend and perform both routine and non-routine analyses from compendial and internal sources.

Responsibilities

• Ensure product testing is completed on time
• Perform routine quality control testing of biologic drug substance, its intermediates, and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations.
• Complete training activities and maintains records, equipment, basic lab supplies, and reagents in accordance with cGMP requirements.
• Work effectively in a team laboratory environment.
• Recognize atypical data, inform supervision of relevant problems, offer possible solutions.
• Knowledge of applicable technical standards, techniques, principles, theories, concepts and Pfizer processes and industry practices/standards.
• Work under minimal supervision
• Contribute to the completion of specific team objectives and assigned project milestones.

Qualifications

• Minimum Requirements: Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
• Demonstrated technical skills in method validation and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
• Strong written and verbal communication skills
• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
• The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
• High productivity and organizational skills.
• Ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position.
• Must demonstrate flexibility/agility and engagement in a changing environment.

Skills

• Experience with laboratory work (Western blot, microbiology/aseptic technique, plate reader/spectrophotometer, HPLC) is preferred
• cGMP documentation experience
• Proven track record in leading continuous improvement projects
• Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
• Strong problem-solving skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels

Education

• No specific degree requirement beyond the Minimum Requirements listed above; degrees should align with the stated experience levels

Additional Requirements

• Physical/Mental Requirements: Ability to lift 40 ‚Äì 60 pounds; Frequent reaching above head; Reasonable accommodations can be made
• Non-standard Work Schedule, Travel Or Environment Requirements: Four 10-hour shifts, Monday through Thursday; Off-shift or weekend work may be required; Occasional travel may be possible