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Catalent · 3 weeks ago

Quality Assurance Document Control Associate

Philadelphia, PA

Full-time

Onsite

Entry, Mid Level

1+ years exp

Catalent is a global leader in drug development and delivery, offering GMP secondary packaging and clinical labeling services. The Quality Assurance Document Control role involves preparing and reviewing batch records, ensuring compliance with regulations, and collaborating with various teams to maintain product quality.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Review and approve batch records before production to ensure compliance with cGMP, clinical trial protocols, and blinding requirements

Monitor production schedules and attend planning meetings as needed to align QA activities with operational priorities

Review completed batch records for accuracy, protocol adherence, and procedural compliance

Verify randomization schedules are correctly applied for patient treatment group assignments

Serve as the primary liaison with clients for batch record review and release

Collaborate with cross-functional teams to resolve documentation issues and ensure compliance with regulations, procedures, and client requirements

Ensure timely batch release to meet protocol initiation dates and update scheduling and inventory systems (e.g., JDE)

Record, track, and analyze documentation errors to maintain and improve departmental quality metrics

Support and coach new QA Document Control staff while promoting a positive, safety-focused work environment

Maintain organized document archives and ensure compliance with EH&S, 5S, and quality system requirements

Other tasks or projects as assigned

Qualification

GMP experienceBatch record reviewDocument controlMicrosoft OfficeSAP/JDEOrganizational skillsTime managementInitiative

Required

High school diploma or GED with a minimum of 5 years of GMP experience in a quality or manufacturing role within a regulated environment OR

Associate's degree with a minimum of 2 years of GMP experience in a quality or manufacturing role within a regulated environment OR

BA/BS degree with a minimum of 1 year of experience in a quality or manufacturing role within a GMP regulated environment

Good organizational/time management skills and ability to multi-task

Challenges status quo and initiates improvements

Preferred

Experience with inspections or batch record review strongly preferred

Advanced computer skills – including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE preferred

Benefits

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Positive working environment focusing on continually improving processes to remain innovative

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

152 hours of PTO + 8 paid holidays

Several Employee Resource Groups focusing on D&I

Dynamic, fast-paced work environment

Community engagement and green initiatives

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement - Let us help you finish your degree or start a new degree!

WellHub- program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2022 (1)