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QA Compliance Specialist - Lowell, United States - Rapid Micro Biosystems
Description
Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before.
Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come.
The sky's the limit.Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation.
Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills.
You'll do more, learn more, and have the ability to make a profound impact on our business.Summary of Primary Responsibilities:
The Quality Assurance (QA) Compliance Specialist performs compliance activities in support of production and engineering; ensuring all activities are performed according to internal Quality System requirements, ISO 9000 standards and the expectations of customers that operate in a cGMP environment.
Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and inspection/approval of incoming materials for release.
The QA Compliance Specialist can perform audits, and can support customer and regulatory audits as part of the Audit Team.
Some microbiological knowledge/experience with aseptic technique is preferred as candidate may periodically provide additional support to quality control testing laboratory.
Strategic Focus Area:
Effectively collaborates with internal colleagues to meet corporate objectives and drive business results.
Specific Responsibilities:
Review and approve QC Lab testing and supportive documents in final release of product Operations.
Review batch records for Systems and Consumables for accuracy and completion prior to final release of product.
Perform Calibration activities.
Support Supplier Management activities.
Performs SAP Transactions.
Review and approve incoming materials for release.
Provide quality assurance support of investigations including: nonconformance and root cause analysis.
Complete audit activities as assigned.
Assist in the maintenance of the Quality System.
Perform support testing for quality control lab as needed (printing/processing EM reports from equipment, growth promotion testing (GPT), leak testing, and pH testing).
Perform other related duties as assigned.
Job Complexity:
Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements.
Supervisor Responsibilities:
None
Required Qualifications:
Bachelor's Degree or relevant experience in the life sciences.
1-2 years minimum experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role.
Knowledge of cGMP requirements is preferred.
Requires computer competence.
Excellent written and verbal communication skills.
Desired Experience, Knowledge, and Skills:
Experience working in a GMP/ISO environment.
Knowledge of some microbiological testing and function tests (i.e. GPT, EM, leak testing, etc.).
Good presentation and organization skills.
Attention to detail.
Capable of executing tasks per defined policies and procedures to resolve routine issues.
ABOUT RAPID MICRO BIOSYSTEMS:
Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.
The company's Growth Direct-the first and only growth-based system to automate rapid compendial QC Micro testing-ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.
Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
Equal Opportunity:
Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position.
Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.
