Glenmark Pharmaceuticals · 3 days ago
Quality Control Document Specialist
Monroe, NC
Full-time
Onsite
Entry, Mid Level
2+ years expGlenmark Pharmaceuticals is seeking a Quality Control Document Specialist responsible for creating and managing documentation for Quality Control functions. The role involves collaboration with cross-functional teams and ensuring compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Gayathri Kirthivasan
Responsibilities
Provide support in resource planning, allocation and manage approved budgets while building best in class quality control procedures
Creates Quality Control documentation and circulates the documents in Document Management System for collaboration and approval
Initiate Quality control Investigations and change controls in Quality Management system
Coordinates the creation and review of relevant records, (e.g. SOP’s, Specifications, Standard Test Procedures, Test Data Sheet, Method transfer/validation protocols/ reports and QMS records, Investigations, etc
Assists in creation of trend analysis reports for Quality Control Investigations
Ensure that site is in state of compliance with CGMPs in respect to internal/external regulations such as USP-NF revisions and introduction of new test methodology and procedures
Provide support in evaluation of implementation for Global Policies and Procedures
Evaluates and assists in the QC documents associated with new products and materials
Supports implementation of projects that improve site Quality and/or efficiency
Support internal and external/regulatory audits / inspections when required
Ensure site is in compliant with CGMPs and internal/external regulations and procedures
Provide guidance and work with stakeholders from various departments to process Quality control documentation, internal and external audit
Provide required support in regulatory documentation
Establish, revise, review and continuously improve procedures for applicable Quality Control
Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target
Qualification
Required
Bachelor of Science (Chemistry, Biology, Pharmaceutical Sciences, or equivalent)
Minimum 2 Years in Quality Control of the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience
Strong understanding of CGMP/GLP and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry
Must be proactive, results-oriented with a strong attention to detail and strong time management skills
Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment
Ability to analyze details and perform structured decision-making skill
Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
Intermediate efficiency for Word, Excel, Power Point skills are required
Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required
Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
Preferred
Any Quality or lean/Six Sigma certifications are a plus
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
2025-12-24
Business Standard India
2025-12-17
Company data provided by crunchbase