Senior Quality Control Specialist

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Title: Senior Quality Control Specialist

Job Summary:

We are seeking a highly skilled Senior Quality Control Specialist to join our team at SUN PHARMA. As a key member of our Quality Control department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Responsibilities:

* Monitor and maintain regulatory compliance related activities, including pharmacopoeia monograph compliance, general chapters, and FDA guidance related to quality control.
* Provide troubleshooting support to chemists in the QC laboratory for new products and support to complete activities timely.
* Support laboratory management in performing investigations, laboratory incidents, and CAPA-related activities to meet cGMP compliance requirements.
* Prepare and review technical documents, including technical reports, gap assessments, and change controls.
* Collaborate with colleagues in AR&D, RA, QC, QA, MSTG, and external partners and vendors or contractors to achieve project goals.

Requirements:

* Minimum BS in Chemistry or equivalent degree in a related discipline; MS preferred.
* Strong and effective people management and interpersonal skills.
* Ability to organize complex work assignments and oversee analysts and staff to complete tasks and projects on time.
* Strong functional knowledge of cGMP compliance.
* Excellent working knowledge of USP, EP, ICH, and FDA guidelines.
* Strong planning, written, and oral communication skills.
* Excellent problem-solving skills.
* Self-starter with a hands-on approach and a can-do attitude.

Work Environment:

* 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.
* While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear.
* The employee is frequently required to stand, walk, sit, and stoop, kneel, crouch, crawl, push, and bend.
* Must be capable of bending and lifting, moving, and/or carrying up to approximately 50-75 pounds.
* Must be able to move pallets/equipment weighing about - pounds using suitable moving equipment such as pallet jacks/Hi-Lo.
* Must have the ability to stand, ambulate, and reach as required by job duties while navigating the office, lab, warehouse, and/or plant floor working environments.
* Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Benefits:

* Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
* In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; (k) savings plan; flexible spending accounts; and the employee assistance program.
* Employees also receive various paid time off benefits, including vacation time and sick time.

EEO Notice:

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics, or any other basis prohibited by law.

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