Job summary
Job post source
This job is directly from Catalent
Job overview
The Senior Quality Assurance Document Control role at Catalent involves coordinating batch record documentation and approvals to ensure compliance and support product release within the pharmaceutical manufacturing process.
Responsibilities and impact
The role requires managing batch record reviews, releasing products, coordinating with production and quality teams, investigating deviations, supporting audits, and maintaining compliance with SOPs and regulatory standards.
Compensation and benefits
The position offers 152 hours of PTO, 8 paid holidays, medical, dental, vision benefits, a generous 401K match, tuition reimbursement, wellness programs, and employee discounts.
Experience and skills
Candidates need a high school diploma with three years of relevant industry experience, cGMP knowledge, and preferably a bachelor's degree and experience in pharmaceutical or medical device environments, especially in QADC and packaging batch records.
Career development
Catalent provides a defined career path, annual performance reviews, and opportunities for growth within an expanding team in a global pharmaceutical company.
Work environment and culture
Catalent promotes a patient-first culture focused on quality and compliance, with a diverse and inclusive environment that encourages innovation and community engagement.
Company information
Catalent is a global CDMO specializing in drug development and manufacturing, supporting pharma, biotech, and consumer health clients with over 40 sites worldwide and producing billions of doses annually.
Team overview
The candidate will join the Quality Assurance Document Control team, coordinating closely with operations, project management, and quality assurance groups to ensure compliance and product release.
Job location and travel
This is a full-time, onsite position Monday to Friday, 8:00 am to 5:00 pm, at Catalent's facility.
Application process
Applicants are advised to apply directly through Catalent Careers, with accommodations available for disabilities via email; unsolicited agency resumes are not accepted.
Unique job features
The role involves unique responsibilities such as managing batch record documentation for clinical trial materials, supporting regulatory audits, and using systems like TrackWise and JDE for quality control and reporting.
Company overview
Catalent, Inc. is a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, and consumer health products. The company generates revenue through its comprehensive suite of services, including drug development, delivery technologies, and supply solutions, catering to pharmaceutical, biotech, and consumer health companies. Founded in 2007, Catalent has grown through strategic acquisitions and innovations, establishing itself as a critical partner in bringing new therapies to market efficiently and reliably.
How to land this job
Tailor your resume to emphasize experience with batch record documentation, review, approval, and release processes in a cGMP-regulated environment, highlighting your ability to ensure compliance with SOPs and regulatory requirements.
Highlight your coordination and communication skills with production, project management, quality assurance teams, and customers, showcasing your capability to manage schedules and support packaging operations effectively.
Apply through multiple platforms including Catalent's official careers page and LinkedIn to maximize your application visibility and ensure it reaches the right hiring teams.
Connect with current employees in Catalent’s Quality Assurance or Document Control teams on LinkedIn, using ice breakers like commenting on recent company initiatives in quality compliance or expressing genuine interest in their role managing batch records and regulatory audits.
Optimize your resume for ATS by including keywords such as 'batch record review,' 'cGMP compliance,' 'SOP adherence,' 'quality assurance,' 'TrackWise system,' and 'document control' to pass automated screenings.
Utilize Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application channels, and discover relevant LinkedIn contacts, allowing you to focus your time on preparation and networking.
Jennie Johnson works for you!
Here’s what we do to make sure you’re successful:
Targeted Resume Revamp:
We expertly craft your resume to navigate Applicant Tracking Systems (ATS) and showcase your qualifications, making you stand out as a top-tier candidate.
Job Description Dissection:
Unpack the job posting with expert analysis, ensuring your application hits every key requirement.
Bespoke Cover Letter:
Capture the attention of hiring managers with a personalized cover letter that highlights how your skills align perfectly with the job's needs.
Interview Mastery:
Prepare for interviews like a pro with likely questions, strategic answers, and insightful questions for you to ask, setting you apart as an informed candidate.
Direct Application Insights:
Receive tailored advice on the best places to apply, ensuring your applications are seen by the right employers.
Skills and Gaps Assessment:
Identify and close critical skills gaps to position yourself as the best-fit candidate for your ideal job.
Personalized Email Pitch:
Make a memorable first impression with an email template crafted to engage potential employers and initiate meaningful conversations.
In-depth Research Guide:
Leverage comprehensive research tools to gather effective insights on companies, industry trends, and role-specific challenges.
Detailed Company Analysis:
Gain in-depth understanding of your prospective employer, giving you the edge in applications and interviews.
Strategic Candidate Overview:
Understand your unique value and why companies would want to interview you, highlighting your background and positioning.