Job Title: Quality Specialist
Client: Medical Equipment Manufacturer
Duration: 4-5 Months
Location: Devens, MA
Shift: 2nd Monday - Thursday 3:45pm - 2:15am
Pay Rate: $26/hour
Job Description
Quality Assurance Specialist I - Contingent Worker
· Executes day-to-day quality assurance objectives following a varied set of procedures, ensuring adherence to company standards and regulatory requirements. Conducts inspections, drafts and reviews quality related documentation, and monitors production processes to maintain product quality and regulatory compliance. Refines testing protocols to accommodate new product designs, troubleshoots unexpected deviations in quality metrics, or adjusts compliance procedures in response to regulatory updates. Communicates with internal and/or external contacts in- and outside of the quality function on matters that involve obtaining or providing information requiring explanation, such as coordinating corrective actions with manufacturing teams, interpreting compliance guidelines for suppliers, and assisting auditors with documentation reviews during inspections.
· Job Duties and Responsibilities
· Supports generation of job packets for Production
· Supports batch record review process.
· Assist in Label generation
· Supports certification requests
· Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
· Ensures documentation and physical product segregation and containment of non-conforming material.
· Reviews production documentation for accuracy, completeness, and GDP compliance.
· Communicates issues / concerns to area owner and direct supervisor or manager.
· Assist with ensuring a state of audit readiness at all times.
· Follows applicable safety procedures
· Document any deviations or non-conformances, following Avantor procedures and Work Instructions, encountered during routine activities.
· Assist in resolving basic quality issues under supervision.
· Collect data for quality reports.
· Order supplies for the quality department when needed.
· Ensures cleanliness of work areas.
· Performs other duties as assigned.
· KNOWLEDGE SKILLS AND ABILITIES
· Good communication, written skills, and interpersonal skills
· Good attention to detail
· Ability to read, understand, and follow procedures
· Ability to escalate issues according to established procedures
· Familiarity with Quality Management Systems
· GMP knowledge is preferred
· Self-motivated and ability to work independently and with a team
· Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
· Good mathematics skills
· Basic understanding of quality standards such as ISO 9001.
· Documentation skills to accurately record test results and quality issues.
QUALIFICATIONS (Education/Training, Experience and Certifications)
· High School completion or equivalent (GED) required.
· Bachelors degree is preferred.
· A minimum of 1-year related experience and/or training in a regulated industry is preferred.
· Experience in a Quality role within the medical device, biotech, or pharmaceutical industry is preferred.
Skills/Experience:
· BioTech pharma, GMP regulations, or ISO requirements experience - preferred
Required Skills:
· Must be comfortable with Word and Excel - used heavily in the role.
Desired Skills:
· The ideal candidate is self-driven - 2nd shift is less supervised than 1st shift.
Will check behind each other's work. Should have a strong attention to detail as there is a lot of record keeping.
Should have the ability to stay on task with routine tasks.
Degree Requirement:
· GED required
Certification Requirements:
· Six Sigmas certification is a plus but not required.
· Power Automate or Power BI programs is a plus but not required.
PrideGlobal and it's affiliates offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity
PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment
PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
Accommodations
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.
Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.
#PNOW
Pay: $25.00 - $26.00 per hour
Work Location: In person
