Chemist (2nd Shift)

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

The Rapid Turn Lab (RTL) Chemist is responsible for scheduling prioritization workload distribution and laboratory process improvement for testing at the Kalamazoo site. This includes communicating priorities to the lab and following up with customers on testing status. The Chemist performs LIR supervisor duties for atypical OOS questionable and invalidated data occurrences and will cover data integrity responsibilities.

The Chemist represents the lab unit or the entire lab organization on moderate complexity projects and project teams both within and outside of Quality Operations. This role provides technical expertise to assist the laboratory with troubleshooting investigations computer validation and instrument qualifications. The chemist may be involved in second checking of data and will perform assays as needed.

This role has the responsibility of serving as Management Designee and will have limited input into the OTE colleague performance assessment process. The chemist may defend QO Laboratory Quality Systems during audits and inspections.

ROLE RESPONSIBILITIES

• Leads and documents laboratory investigations for procedural deviations atypical OOS questionable and invalidated data occurrences.

• Assures adherence to data integrity initiatives.

• As a Subject Matter Expert (SME) represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems.

• Assists QO Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.

• Performs data quality inspection through Quality audits and 2nd check of laboratory data packets

• Performs analytical assays during times of need.

• Demonstrates a technical mastery of one or more techniques in fields such as: wet chemistry chromatography physical chemistry or spectroscopy as well as a complete knowledge of laboratory operations including both technical and compliance aspects.

• Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.

• Trains others in the theory and practice of both laboratory techniques and quality systems including investigations instrument qualifications etc.

• Independently writes SOPs technical reports project plans instrument qualifications etc.

• Supports and may lead implementation of various elements of IMEx.

• Performs analytical assays during times of need

• Serves as management designee and will have limited input into the OTE colleague performance assessment process.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Demonstrated technical skills in 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)

• Laboratory Investigation Report Author

• Trained to execute and record check multiple Chemistry laboratory technologies

• Experience with laboratory work particularly using analytical HPLC (High Pressure Liquid Chromatography) techniques

• 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

• Abilityto 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 procedures

PHYSICAL/MENTAL REQUIREMENTS

Job requires sitting standing walking ability to type and dexterity for handling glassware/laboratory equipment.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

2nd Shift 3:00pm -11:30pm Monday through Friday

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.