QC Lab Analyst

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.

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.

What You Will Achieve

In this role, you will:

• 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.

Here Is What You Need (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. 

Bonus Points If You Have (Preferred Requirements)

• Experience with laboratory work (Western blot, microbiology/aseptic technique, plate reader/spectrophotometer, HPLC)

• 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

PHYSICAL/MENTAL REQUIREMENTS

• Ability to lift 40 – 60 pounds.

• Frequent reaching above head.

• Reaso