Top 15 Quality lab specialist Jobs in Allegan Mi

Quality Lab Specialist
Praxis Packaging —Grand Rapids, MI
- Extended hours
- Mid-level
- 3 years
- Master's degree
13d
Quality Lab Specialist
Praxis Packaging Solutions —Grand Rapids, MI
- Extended hours
- Mid-level
- 3 years
- Master's degree
13d
Quality Lab Technician
WORKFORCE Employment Specialists —Holland, MI
- $19.55 an hour
- Analysis skills
- Experience equivalent to degree accepted
- Associate's degree
Quick Apply
Pathology Support Specialist
WMU Homer Stryker, M.D. School of Medicine —Kalamazoo, MI
- $19.65 - $22.92 an hour
- Overtime
- 5 years
- Writing skills
- English
- Health savings account
- Paid holidays
Quick Apply
1d
Cath Lab RN Documentation Specialist / Scheduling RN - Bronson Methodist Hospital - Full-time Days
Bronson Healthcare —Kalamazoo, MI
- Full-time
- Nursing
- RN License
- Hospital
7d
Cardiovascular Special Procedure Tech, Full-Time, Variable Hours, Bronson Methodist Hospital
Bronson Healthcare —Kalamazoo, MI
- Weekends as needed
- Laboratory
- Hospital
- Computer literacy
4d
Faculty Specialist I / Faculty Specialist II - Lecturer - Tenure Track
Western Michigan University —Kalamazoo, MI
- Laboratory
- Classroom
- Doctoral degree
- Disability insurance
- Health insurance
Lead Med Lab Scientist
Beacon Health System —Kalamazoo, MI
- Overtime
- Hospital
- Writing skills
- Research
Quick Apply
APP Urology - Inpatient
Bronson Healthcare —Kalamazoo, MI
- 12 hour shift
- Acute care
- Hospital
- Word processing
- Relocation assistance
APP - Outpatient Neurology
Bronson Healthcare —Kalamazoo, MI
- Full-time
- Word processing
- Writing skills
- Outpatient experience
11d
APP IP/OP Neurology
Bronson Healthcare —Kalamazoo, MI
- Full-time
- Acute care
- Word processing
- Writing skills
Public Safety Officer (PSO) - CERTIFIED PROCESS ONLY (67A*)
City of Kalamazoo, MI —Kalamazoo, MI
- $55,779.36 - $92,907.36 a year
- 12 hour shift
- Pass drug screening
- No experience needed
- Mid-level
- Paid holidays
- Disability insurance
APP Hospitalist NP or PA-C
Bronson Healthcare —Kalamazoo, MI
- Weekends as needed
- Word processing
- Writing skills
- Internal Medicine
- Relocation assistance
Staff RN - ECMO Spec / FT, nights
Children's Nebraska —United States
- Overtime
- Nursing
- RN License
- BLS Certification
- Flexible schedule

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Quality Lab Specialist
Praxis Packaging —Grand Rapids, MI
The Quality Lab Specialist will ensure the compliance with requirements of 21CFR Part 211 section 211.22 (a) (c) and consistency of our manufacturing processes…
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quality lab specialist jobs near allegan mi

Quality Lab Specialist

Praxis Packaging -
Grand Rapids, MI

Apply Now

Job Details

Full-time
13 days ago

Qualifications

Safety regulations
Regulatory/legal compliance standards in production

Full Job Description

Overview:

At Praxis, quality isn't just a requirement, it's our promise. As a Quality Lab Specialist, you'll be at the forefront of safeguarding product integrity for leading OTC pharmaceutical brands through advanced analytical testing, data-driven investigations, and continuous improvement. This is an exciting opportunity to join a fast-growing contract packaging manufacturer where your expertise directly influences customer trust, regulatory compliance, and operational excellence.

The Quality Lab Specialist will ensure the compliance with requirements of 21CFR Part 211 section 211.22 (a) (c) and consistency of our manufacturing processes through rigorous testing and analysis.

Responsibilities:

Essential Functions and Responsibilities:

C Conduct Quality Control Testing:

Execute a variety of chemical and physical analyses on raw materials, intermediates, and finished products to guarantee compliance with established quality standards.
Utilize analytical instrumentation, including but not limited to HPLC (High Performance Liquid Chromatography), Gas Chromatography, Karl Fisher, Viscometer, Specific Gravity, and pH to perform quantitative and qualitative analyses.
Perform method transfer and verification for new testing methods in the laboratory.
Perform recovery studies and Total Organic Carbon (TOC) testing in support of cleaning validations.

D Data Analysis and Troubleshooting:

Perform data analysis, identify trends, and troubleshoot issues, taking corrective actions as necessary.

C Compliance and Approval Checks:

Ensure products meet specifications and conduct final product approval checks.
Confirm label claims adhere to quality control specifications.

D Documentation, Record-Keeping, and Quality Assessment:

Develop and gain approval on critical laboratory SOPs, Methods, forms and reports.
Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
Author, execute and gain approval on laboratory validation protocols.
Maintain meticulous and precise records of all testing procedures, results, and any deviations from anticipated outcomes.
Generate Certificates of Analysis (CoA) for each product batch, providing comprehensive documentation of quality specifications.
Assess daily quality parameters and quality systems, covering cross-checks, raw materials, calibration, maintenance, procedures, training, auditing, and oversight of analytical testing.
Document standard operating procedures and identify trends in testing results using data analysis from daily result entries.

T Training and Support:

Train new quality chemists, and provide technical support to stakeholders, investigating quality problems and implementing actions to follow up.

T Troubleshoot and Investigate:

Identify and investigate any discrepancies in quality standards, collaborating with production and relevant departments to promptly resolve issues.
Utilize technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.

C Continuous Improvement:

Participate in continuous improvement initiatives by suggesting and implementing enhancements to existing testing methods and processes.
Establish and maintain a system to ensure proper supplies in the laboratory.
Ability to train and mentor junior scientists.

C Compliance and Safety:

Guarantee that all quality control activities adhere to industry regulations and safety standards.
Contribute to maintaining a safe, clean, and orderly laboratory environment.
Participate in internal/external audits as needed.

Other duties:

Flexibly to work other shifts, and extended hours.
Perform additional duties as assigned.

Qualifications:

Knowledge & Experience:

Knowledge of analytical chemistry at a level normally acquired through completion of a bachelor’s degree in chemistry or equivalent. Master’s degree in chemistry is a plus
3 years’ work experience in a chemistry analytical laboratory, including proficiency and understating in the following areas:
- Analytical techniques and instruments.
- Complex laboratory analysis including but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay Analysis, working LC-MS knowledge strongly preferred.
- TOC Analysis, TLC, ICP-MS Analysis, UV-Vis, and USP Compendial Testing preferred.
- Stability Program Management.
- Method qualification, validation, and transfer.
- Wearing appropriate PPE and following safety guidelines.
Previous experience with pharmaceutical manufacturing & testing highly preferred; understanding of compliance requirements and regulatory expectations required.
Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
Strong oral and written communication skills demonstrated through documentation and presentations.
Demonstrated strong interpersonal interaction skills.
Ability to work in cross functional teams as well as across networks.

Exceptional attention to detail and accuracy in documentation.

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Refine Your Search

quality lab specialist jobs in allegan mi

Quality Lab Specialist

Quality Lab Specialist

Quality Lab Technician

Pathology Support Specialist

Cath Lab RN Documentation Specialist / Scheduling RN - Bronson Methodist Hospital - Full-time Days

Cardiovascular Special Procedure Tech, Full-Time, Variable Hours, Bronson Methodist Hospital

Faculty Specialist I / Faculty Specialist II - Lecturer - Tenure Track

Lead Med Lab Scientist

APP Urology - Inpatient

APP - Outpatient Neurology

APP IP/OP Neurology

Public Safety Officer (PSO) - CERTIFIED PROCESS ONLY (67A*)

APP Hospitalist NP or PA-C

Staff RN - ECMO Spec / FT, nights

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