Quality Control Document Specialist

POSITION SUMMARY:

Under the direction of the Assistant Manager / Manager, Quality Control, the Quality Control Document Specialist is responsible for creating and managing the documentation required for Quality Control functions such as creating and revising specifications, standard test procedures, test data sheet with aid of change controls, assisting in creation of Standard operating procedures, change controls as well as working with supervisors to aid investigational write-up’s along with creation of protocols and reports for methods. This individual works closely with cross-functional teams at the site and abroad. This position will also provide site representation for regulatory surveillance programs including pharmacopeial updates.

JOB RESPONSIBILITIES:

Financial

• Provide support in resource planning, allocation and manage approved budgets while building best in class quality control procedures

Operational Excellence

• 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.

Stakeholder

• 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.

Innovation

• 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.

KNOWLEDGE, SKILLS AND ABILITIES

Education

Bachelor of Science (Chemistry, Biology, Pharmaceutical Sciences, or equivalent)

Experience

Minimum 2 Years in Quality Control of the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills (Functional / Technical)

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

Leadership / Managerial Attributes

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.

Other requirements (licenses, certifications, specialized training)

Any Quality or lean/Six Sigma certifications are a plus.