Quality Control Manager

Woburn, MA, United States

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 www.azurity.com .

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.

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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.

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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.

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