Job Application for Quality Assurance Specialist III at Precision Medicine Group

New

***This job requires you to be onsite 5 days a week in Norton, MA or Mansfield, MA. ***

Position Summary:

The Quality Assurance Specialist III will provide on-site advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for managing the document and record control system. Extended work hours may be necessary in order to meet business demands.

Essential functions of the job include but are not limited to:

Quality Function:

Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):

*Non-Conformances

*Customer Complaints

*Planned Deviations

*Change Management

*Corrective and Preventive Action (CAPA)

*Supplier Quality Management

*Audit Programs

*Employee Training

*Document & Record Control

Participating on the Material Review Board and Safety Committee
Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities; serve as lead auditor
Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions
Respond to supplier look-back notifications. Investigate and determine disposition of material
Support laboratory management with monitoring equipment calibration program to ensure timely and accurate completion of maintenance
Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
Lead departmental projects aimed operational process understanding efforts (process mapping)
Act as a change-agent and QA lead during continuous improvement and global harmonization efforts
Provide guidance to junior level QA specialists
Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints
Create and conduct site-wide training for multiple disciplines

Operations Support:

Serve as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentation
Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
Generate and maintain label formats for manufactured and resale products
Generate and maintain Certificates of Analysis for finished products and products for resale
Inspect and approve all product labels generated by Operations
Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
Develop and distribute controlled quality system documentation
Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
Develop and maintain databases/spreadsheets for document control
Maintain filing and storage systems for document control, training and batch records for raw and finished product
Perform area walkthroughs and audits for compliance to written expectations
Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability

Inspection and release:

Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
Perform batch record review and release for finished product, raw materials, intermediate solutions, and services
Conduct product inspections, review repack records

Miscellaneous:

Assist in training new and existing personnel
Participate in regulatory, notified body, and customer audits as needed
Provide back-up coverage for other Quality Specialists
Carry out other duties/projects as assigned
Clinical quality experience preferred but not required

Qualifications:

Minimum Required:

Bachelor’s Degree or equivalent combination of education and experience
4 years of related experience in a life science, regulated environment

Other Required:

Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection
Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
Must become an active member of Society for Quality Assurance (SQA). Company will support the membership fees.
Ability to meet deadlines and perform administrative functions
Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
Ability to organize tasks, work independently and adapt to changing priorities
Ability to function independently within a minimally supervised environment with exceptional attention to detail required
Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
Must be able to read, write, speak, fluently and comprehend the English language

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$1 - $1 USD

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

First Name

Last Name

Phone

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

School

Select...

Degree

Select...

Discipline

Select...

Start date year

LinkedIn Profile

What is your desired salary?

Are you authorized to work lawfully in the country/location for which you are applying?

Select...

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status.

Select...

Are you able to be onsite in Norton, MA or Mansfield, MA 5 days a week?

Select...

Please describe your experience working in a lab.

Please experience your experience in GMP, GLP, GXP.

Have you ever worked for Precision Medicine Group or one of its affiliated companies?

Select...

If yes, when and which company?

If you have performed an audit, did you do it alone?

Select...

Have you ever interviewed with Precision Medicine Group or an affiliated company?

Select...

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer?

Select...

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States. This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply. UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

Select...

Legal Address - Street Address 1

Legal Address - Street Address 2

Legal Address - City

Legal Address - State

Select...

Legal Address - Zip

Legal Address - Country

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Precision Medicine Group’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Quality Assurance Specialist III

Apply for this job

Voluntary Self-Identification

Voluntary Self-Identification of Disability