Associate II, Quality Control - Raw Material

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.

What You Will Achieve

In this role, you will:

• Perform various chemical tests such as water analysis, FTIR, ID, HPLC, and other compendial assays.

• Write and perform raw material verification protocols and associated reports.

• Ensure training records are updated and correctly filed to reflect current testing capabilities.

• Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.

• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.

• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.

• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.

• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.

• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.

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 chemistry laboratory 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.

• Excellent organizational skills and strong ability to multi-task

• Strong written and verbal communication skills

• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation

Bonus Points If You Have (Preferred Requirements)

• Experience with laboratory work, particularly using analytical techniques such as HPLC, pH, Polarimetry, etc.

• 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

• Adaptability and willingness to learn new techniques and procedure.

  

PHYSICAL/MENTAL REQUIREMENTS

• Non-existent to minimal travel. 

• Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.) 

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets. 

• Intellectual capability to perform complex mathematical problems and perform complex data analysis. 

Work Location Assignment: On Premise

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefit