Quality Control Manager - Woburn, United States - Azurity Pharmaceuticals - US

Description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients.

As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.

For more information, visit .
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer.

Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do.

We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
The Quality Control Manager will ensure the QC laboratories are set up to support production and the stability program

while ensuring that data results from the lab are accurate and precise. The lab manager creates systems to monitor data

quality and performance. They also confirm that procedures adhere to safety and compliance rules and regulations. The

Quality Control Lab Manager provides supervision, leadership, and training to laboratory analysts as necessary.

Primary Responsibilities:
Provide leadership in the QC organization to ensure compliance, drive improvements and achieve schedule adherence
Work with cross-functional teams to align testing schedules to meet production needs
Manage applicable deviations, CAPAs and investigations
Manage Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
Stays current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Laboratories are compliant and continuously improved upon
Participates in the hiring on laboratory staff
Review and approve test data as needed
Attends project meetings and prepares project updates
Maintain a safe, clean, well-organized, and efficient laboratory work environment
Represent the QC Director in his/her absence.
Additional responsibilities as assigned by the QC Director

Qualifications:
Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
Understand procedures and policies, Good Documentation Practices and Good Laboratory Practices
Ability and drive to solve practical problems
Strong organizational skills and project management skills
Excellent written and verbal communication skills with high attention to detail
Demonstrates ability to exercise good judgment and make decisions quickly
Minimum BSc. in Life Sciences, Chemistry or Biology preferred
Minimum 5-7 years related experience in a CGMP QC lab of pharmaceutical industry

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to sit for long periods of time
While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
The employee must occasionally lift and/or move up to 25 pounds
Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required

Benefits We Offer:

Unlock Your Earning Potential:

Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.

Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.

Fuel Your Success:

• Sales Only
• We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.

Comprehensive Health Coverage:

We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.

Flexibility for Your Lifestyle:

Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office.

* Excludes Sales, Manufacturing, and some Operations positions*Start Your Week on a

High Note:
Indulge in our "Bagel Tuesday" perk, where you can enjoy a fresh bagel on us every Tuesday morning.


Only for On-site/Hybrid colleagues

Invest in Your Future:

Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.

Time Off That Counts:
Take advantage of our generous PTO policy, which offers 20 days annually + rollover (up to 40 hours).
Meaningful Time with

Your Loved Ones:

We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.

Enjoy the Holidays:
Over the course of the year, Azurity recognizes 13 holidays.

Summer Vibes:
Embrace the summer season with our Summer-Hours perk, available between Memorial Day and Labor Day.


Excludes Sales Colleagues

Invest in Your Education:
We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.

Recognize and Be Recognized:

Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation

(GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
Prior to employment, you must consent to a background check and drug screen. Please acknowledge this requirement.

• Were you referred to this job by a current employee at Azurity Pharmaceuticals?
• If you answered yes to being referred, please tell us who referred you

Will you now or in the future require sponsorship for employment?

• 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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Azurity Pharmaceuticals - US's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Classification of protected categoriesis 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.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number
Expires 04/30/2026
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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Azurity Pharmaceuticals - US's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Please select

Gender

Are you Hispanic/Latino?

Please select

Are you Hispanic/Latino?

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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Classification of protected categoriesis 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

Please select

Veteran Status

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number

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 .
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

Please select

Disability Status*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.

Azurity Pharmaceuticals - US has my consent to collect, store, and process my data for the purpose of considering me for employment, and for up to 60 days thereafter.

#J-18808-Ljbffr