Chemist (2nd shift)

Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Chemist (2nd shift).

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of the company’s dedicated and highly effective quality control team. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to analytical testing will help the company provide safe drugs to its patients.

Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making the companyready to achieve new milestones and help patients across the globe.

The Rapid Turn Lab 2nd shift chemist is responsible for scheduling prioritization, workload distribution, and laboratory process improvement for the Rapid Turn Lab 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.

How You Will Achieve It

• 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.

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

Qualifications

Must-Have

• HS Diploma with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience
• Demonstrated technical skills
• 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

Nice-to-Have

• Laboratory Investigation Report Author
• Trained to execute and record check multiple Chemistry laboratory technologies
• Experience leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics

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: standard hours 3pm - 11:30pm

Relocation support available

Work Location Assignment: On Premise

Last Day to Apply: October 4th, 2023.

Relocation: YES

Referral Bonus: YES

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

Sunshine Act

The Company reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require the Company to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which the Company intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

The Company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. The Company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. The Company is an E-Verify employer.

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person