Associate Scientist, QC Chemistry

The position will support Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation.  Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.

Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.

At a minimum, the individual should be considered able to demonstrate the following:

Acts safely and follows all EH&S safety requirements for site and QC laboratories

Sufficient depth of knowledge within their scientific discipline and previous area of experience

Good written and verbal communication techniques

Ability to follow written procedures and learn from hands on training

Capability of solving complex mathematical and situation dependent problems

Ability to receive feedback and take accountability for actions and personal development

Aptitude for good decision making based on procedures, guidance, and experience

Awareness to know their own limitations and seek senior scientist or management guidance when appropriate

Desire to ensure correctness and accuracy in tasks and documentation

Fitness of functioning as a team member and performing independent work with minor guidance

Willingness to use personal skills and knowledge to achieve individual and company goals and objectives

Understanding of own area of function and knowledge of other cross functional areas

Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching

Understands the importance of feedback and receives feedback well from management and other colleagues

Makes good decisions based on knowledge of quality systems and technical experience

Recognizes the impact of procedural changes that may impact future quality tasks and decisions

Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations

Responsible for personal timelines and seeks advice if conflicts arise

Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines

Ability to communicate effectively with good interpersonal skills

How You Will Achieve It

Performs testing including, but not limited to, clinical product, commercial product, raw materials, and validation samples.

Analyzes and interprets results, makes decisions regarding the accuracy, completeness, and compliance.

Creates, reviews and approves GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) while ensuring adherence to Pfizer standards, guidelines and values.

Reports issues to management and participates in issue resolution, such as reporting OOS results, participating laboratory investigations, reporting instrument issues, troubleshooting instruments, etc.

Assesses existing situations and suggesting improvements to increase compliance and innovation.

May perform data trending activities and assist with metrics reporting.

May initiate and develop project plans to ensure projects timely completion.

May serve on cross functional teams to facilitate communications between Quality Control and other departments.

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 experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry

Fundamental understanding of laboratory instrumentation function and analytical testing and use of analytical equipment.

Aptitude for good decision making based on procedures, guidance, technology, and experience

Effective communication skills

Knowledge of Microsoft Office applications, specifically Word and Excel

Bonus Points If You Have (Preferred Requirements)

A deep understanding of Chemistry testing and experience in defending laboratory practices during regulatory audits

2+ years of QC Chemistry Laboratory experience

1+ years of HPLC experience

Proficiency in both viable and non-viable environmental monitoring within pharmaceutical manufacturing

Solid grasp of aseptic techniques

Strong problem-solving skills

Computer programing knowledge

Ability to work independently and as part of a team

Ability to manage multiple tasks simultaneously

PHYSICAL/MENTAL REQUIREMENTS

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work schedule 4 days a week 10 hours each day. Sunday to Wednesday (8:30 am to 7:00pm) but can include other weekdays and/or weekend days as appropriate for assigned tasks/activities Minimal off-shift work to ensure business needs are met.

Not expected to travel.

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