QA Associate I - Batch Record Reviewer
New Brunswick, New Jersey
- Temps plein
- Niveau : Premier
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Overview
Vous serez la personne qui nous aidera à atteindre et à dépasser les normes de qualité que les professionnels de la santé et les patients attendent de nous. En collaborant avec des collègues inventifs qui partagent les mêmes idées, vous adoptez une approche équilibrée, vous relevez les défis, vous apprenez de vos erreurs et vous créez des solutions aptes à habiliter notre entreprise en pleine croissance. Joignez-vous à un lieu de travail qui mise sur une communication ouverte et sur le développement de votre carrière. Quand pouvez-vous commencer à travailler chez nous?
Profil de réussite
Quels sont les points forts d’un excellent QA Associate I - Batch Record Reviewer chez Sun Pharma? Jetez-y un coup d’œil et voyez si cela vous en dit.
- Collaboratif
- Communicateur
- Orienté vers les détails
- Indépendant
- Résolveur de problèmes
- Esprit d’équipe
Notre culture
Découvrez un environnement ouvert et transparent. Chaque jour présente une nouvelle occasion d’apprendre et de grandir, entourée de puissants rappels de l’impact de votre rôle sur la vie des patients. C’est le mode de vie au sein de Sun Pharma. Et nous avons hâte que vous en fassiez partie.
Avantages sociaux
Nous sommes à vos côtés de bien des façons. Sun Pharma souhaite que vous profitiez des avantages, du soutien et des récompenses d’un travail bien fait.
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Développement de carrière
Obtenez du soutien pour votre développement de carrière et votre perfectionnement.
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Programmes d’avantages sociaux
Découvrez des avantages sociaux complets pour favoriser votre santé et votre bien-être, ainsi que ceux de votre famille.
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Congés
Profitez des options de congés payés et de congés autorisés.
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Rémunération
Obtenez une rémunération concurrentielle grâce à des programmes incitatifs qui récompensent notre succès commun.
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Conditions de travail
Travaillez en toute confiance dans un milieu de travail sécuritaire, propre et réglementé que nous promouvons.
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Environnement d’équipe
Collaborez dans un milieu de travail ancré dans nos valeurs et encourageant l’engagement entre les équipes.
QA Associate I - Batch Record Reviewer
New Brunswick, New JerseyDriven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.
As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.
Are you passionate about quality and excited to support the release of products that make a difference? Join our Quality Assurance team as a QA Associate I, where you’ll play a key role in ensuring every batch meets the highest standards of compliance, accuracy, and documentation excellence.
In this role, you’ll apply your attention to detail and cGMP knowledge to support batch record review, deviation identification, compliance activities, and readiness for regulatory inspections. You’ll collaborate cross-functionally, contribute to quality initiatives, and help maintain our culture of audit-readiness and continuous improvement.
Area Of Responibility:
As a QA Associate I, you will support the end‑to‑end quality process, including:
Batch Review & Release
- Review and release Commercial, Process Validation, and Exhibit batches.
- Execute conditional and final Usage Decisions in SAP.
- Identify deviations during BMR/PBR review and initiate TrackWise deviations when required.
- Manage batch record closure and document archival.
Quality Systems & Compliance Support
- Support DEA inventory management and annual retain sample inspections.
- Assist with annual stability sample tracking and submission.
- Prepare QA reports and PowerPoint presentations for review and release activities.
- Support ongoing MBR/PBR review and archival processes and product quality complaint investigations as needed.
Audit & Regulatory Readiness
- Support FDA (GMP & Pre‑Approval) and customer audits through document preparation, response coordination, and general audit‑readiness tasks.
- Provide required input for Annual Product Reviews.
General QA Support
- Maintain accurate documentation aligned with cGMP expectations.
- Complete additional assignments as directed by the Senior Associate or IPQA Section Head.
Work Environment:
You will work across office, lab, and manufacturing environments with moderate noise levels. This role requires comfort navigating dynamic production and quality spaces and following all required safety protocols.
Work Schedule:
- Monday-Friday 9:00am-5:30pm. (Flexibility to work over time on weekedns as needed)
Physical Requirements:
- Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, push, and lift up to 20 lbs.
- Ability to move throughout office, laboratory, and manufacturing areas.
- Must be able to wear required PPE (e.g., respirators, gloves, safety glasses, safety shoes).
Travel: 0%
What You Bring:
Education & Skills
- Bachelor’s degree required.
- Understanding of GMP requirements.
- Proficiency in MS Office (Word, Excel, Outlook, PowerPoint), Acrobat, SAP, TrackWise or similar QMS, and LMS systems.
- Strong verbal and written communication skills.
- Excellent organizational skills with the ability to manage multiple priorities.
- A proactive, self‑starting mindset with a hands‑on, solutions‑oriented approach.
- English language proficiency at CEFR Intermediate B1+.
Experience
- Minimum 2 years of experience in the pharmaceutical industry in a quality role.
- Experience with solid oral dosage forms.
- Experience working in a multicultural, matrixed organization.
Why Join Us?
- Make a direct impact on product quality and patient safety.
- Work with a supportive, collaborative quality team.
- Gain exposure to key QA systems, audits, and regulatory expectations.
- Build a strong foundation for growth within the Quality function.
Ready to make a difference? Apply today and help us uphold the highest standards inpharmaceutical compliance!
The presently-anticipated base compensation pay range for this position is $35.00/hr to $39.66/hr. Actual basecompensation may vary based on a number of factors, including but not limited to geographical location andexperience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the
LongTerm Incentive Plan
. Employees are eligible to participate in Company employee benefit programs which includemedical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts;and the employee assistance program. Employees also receive various paid time off benefits, including vacation timeand sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans,policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limitedto terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reservesthe right to modify base salary (as well as any other discretionary payment or compensation program) at any time,including for reasons related to individual performance, Company, or individual department/team performance, andmarket factors.
The preceding job description has been designed to indicate the general nature and level of work performed byemployees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of allduties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall precludethe employer from changing these duties from time to time and assigning comparable duties or other dutiescommensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policymeans 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 orveteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signedsearch agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as aresult of an unsolicited agency or search firm referral.
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