Quality Assurance/Quality Control Manager
Marin Biologic Laboratories Marin Biologic Laboratories Novato, CA Novato, CA Full-time Full-time Estimated:
$77.
7K - $98.
4K a year Estimated:
$77.
7K - $98.
4K a year We're seeking a QA Manager, full-time, with benefits, to provide support to QA/QC functions, working onsite at our lab located in Novato, CA.
The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to support GLP, GMP testing and documentation to meet the FDA's 21 CFR Part 210, 211, and 600 regulations requirements.
The manager will develop and maintain the Quality Management System that safeguards product quality and fosters a culture in which all employees are actively engaged.
Marin Biologic Laboratories, (Marin Bio) is a contract research organization working with the pharmaceutical and biotechnology industries.
Our scientists develop and validate drug release assays, perform drug stability studies and research surrounding this effort.
The scientific areas include molecular and cellular biology, immunology and biochemistry.
Marin Bio is a small company that strives for the best quality in our work and communications with our clients, as well as a balance life for our staff.
RESPONSIBILTIES Assist in the development and maintenance of our Quality Management System by writing, reviewing and updating Quality Documents Administer the Document Control system including documentation and tracking of requests, approvals and implementation Maintain master documents and records, training records, audit files and raw data Experience with data integrity and specifically with 21 CFR Part 11 and ALCOA
Execute QA and QC operations required to assess, evaluate, and review operations on the research floor and observe real-time observation of activities.
Also, identify and resolve issues including proper and timely documentation Supports customer audits and regulatory inspections Perform review and approve documentation, deviations, internal laboratory investigations and CAPAs Work closely with other staff to develop, review, and approve the systems for Change Control, CAPA, Deviations, Complaints and Internal Audits Utilize quality tools and techniques to perform and document root cause analysis investigations, evaluate and resolve quality issues, and enhance continuous improvement Perform training and support that covers policies, procedures and core processes EDUCATION Bachelors degree in Chemistry, Biochemistry, Molecular or Cell Biology preferred or equivalent work, GMP/GDP training and experience EXPERIENCE Minimum 3
years in Quality Assurance preferred Experience managing Deviation, CAPA, Change Control, Audit, Scientific Review, and Quality Control documents Knowledge of IQ/OQ/PQ protocols, equipment validation and Continuous Improvement techniques Familiarity with basic analytical data analysis and QA/ QC tools and methods SKILLS REQUIRED Knowledge of GMP, GLP and FDA standards Good Documentation Practices (GDP) and reporting skills Excellent written and verbal communication skills Ability to work independently Strong Organizational skills Excellent problem-solving, analytical and decision-making skills Strong attention to detail and timelines Deep knowledge of quality assurance terminology, methods and tools Microsoft Office skills Ability to prioritize and manage several projects and activities simultaneously Teamwork and collaboration with MBL staff Authorized to work in the U.
S.
SKILLS DESIRED Strong technical writing/editing skills Proficiency in database management Experience with Regulatory Inspections with the ability to act as a Subject Matter Expert Demonstrates positive attitude, strong work ethic, and self-motivation Fast learner, able to react quickly in a fast-paced environment Customer Service / Quality Driven TO APPLY Please send resume to marinbio378@marinbio.
com A cover letter Include 3 references (email, address and phone number, as well as your relationship to each reference) Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Novato, CA 94949:
Reliably commute or planning to relocate before starting work (Required)
Experience:
ISO 9001:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
$77.
7K - $98.
4K a year Estimated:
$77.
7K - $98.
4K a year We're seeking a QA Manager, full-time, with benefits, to provide support to QA/QC functions, working onsite at our lab located in Novato, CA.
The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to support GLP, GMP testing and documentation to meet the FDA's 21 CFR Part 210, 211, and 600 regulations requirements.
The manager will develop and maintain the Quality Management System that safeguards product quality and fosters a culture in which all employees are actively engaged.
Marin Biologic Laboratories, (Marin Bio) is a contract research organization working with the pharmaceutical and biotechnology industries.
Our scientists develop and validate drug release assays, perform drug stability studies and research surrounding this effort.
The scientific areas include molecular and cellular biology, immunology and biochemistry.
Marin Bio is a small company that strives for the best quality in our work and communications with our clients, as well as a balance life for our staff.
RESPONSIBILTIES Assist in the development and maintenance of our Quality Management System by writing, reviewing and updating Quality Documents Administer the Document Control system including documentation and tracking of requests, approvals and implementation Maintain master documents and records, training records, audit files and raw data Experience with data integrity and specifically with 21 CFR Part 11 and ALCOA
Execute QA and QC operations required to assess, evaluate, and review operations on the research floor and observe real-time observation of activities.
Also, identify and resolve issues including proper and timely documentation Supports customer audits and regulatory inspections Perform review and approve documentation, deviations, internal laboratory investigations and CAPAs Work closely with other staff to develop, review, and approve the systems for Change Control, CAPA, Deviations, Complaints and Internal Audits Utilize quality tools and techniques to perform and document root cause analysis investigations, evaluate and resolve quality issues, and enhance continuous improvement Perform training and support that covers policies, procedures and core processes EDUCATION Bachelors degree in Chemistry, Biochemistry, Molecular or Cell Biology preferred or equivalent work, GMP/GDP training and experience EXPERIENCE Minimum 3
years in Quality Assurance preferred Experience managing Deviation, CAPA, Change Control, Audit, Scientific Review, and Quality Control documents Knowledge of IQ/OQ/PQ protocols, equipment validation and Continuous Improvement techniques Familiarity with basic analytical data analysis and QA/ QC tools and methods SKILLS REQUIRED Knowledge of GMP, GLP and FDA standards Good Documentation Practices (GDP) and reporting skills Excellent written and verbal communication skills Ability to work independently Strong Organizational skills Excellent problem-solving, analytical and decision-making skills Strong attention to detail and timelines Deep knowledge of quality assurance terminology, methods and tools Microsoft Office skills Ability to prioritize and manage several projects and activities simultaneously Teamwork and collaboration with MBL staff Authorized to work in the U.
S.
SKILLS DESIRED Strong technical writing/editing skills Proficiency in database management Experience with Regulatory Inspections with the ability to act as a Subject Matter Expert Demonstrates positive attitude, strong work ethic, and self-motivation Fast learner, able to react quickly in a fast-paced environment Customer Service / Quality Driven TO APPLY Please send resume to marinbio378@marinbio.
com A cover letter Include 3 references (email, address and phone number, as well as your relationship to each reference) Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Novato, CA 94949:
Reliably commute or planning to relocate before starting work (Required)
Experience:
ISO 9001:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
