What are the responsibilities and job description for the QA Technician II position at TekOne IT Services Pvt. Ltd.?
Role: QA Technician II
Location: Westbrook, ME - 04092
Duration: 06 Months
Responsibilities
Quality System Management
Location: Westbrook, ME - 04092
Duration: 06 Months
Responsibilities
Quality System Management
- Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production.
- Review finished goods batch records. Report deviations in these records and assures these have been addressed and resolved prior to issuing approval.
- Conduct spot-check inspections/audits of production operations
- Participate in the internal audit program
- Write, review and approve Standard Operating Procedures (SOPs) as necessary
- Assist with and may write validations/test protocols as necessary
- Assist in testing of complaint samples and stability samples and reports results out of acceptance limits
- Provide backup to other Quality Specialists
- Initiate and author Deviations and Quality Incidents (QI)
- May administer the calibration program.
- May administer the Document Control program
- May administer the Deviation, Quality Incident and CAPA programs .
- May organize the long term stability program and be responsible for administering the sample retention program.
- May administer the Quality Records program and assist and act as backup to the Document Control Specialist II (with administrator rights in site electronic documentation system).
- Train new and current Quality Assurance Technician and Specialists as needed
- Other duties as assigned
- Change Management Documentation
- Assignment of Design History File numbers
- Compile and maintain quality system records associated with design change
- projects, including project definitions, first-lot-to-stock, product qualification records, etc.
- Ensure records for design change projects are complete and align with SOPs.
- Manage organization, storage, and archival of documentation and records associated with design changes and labeling.
- Provide proofreading of product labeling prior to team review and approval.
- Initiate, execute and implement label changes in coordination with interdepartmental and external stakeholders.
- Assist with implementation of product changes, in conjunction with project leads.
- Manage assigned Design Change projects (Typically associated with product labeling)
- Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a scientific or technical area or the equivalent combination of education and experience
- Minimum three years in a Quality Assurance role for manufacturing.
- 3 years prior experience in a Quality Assurance role or similar support role in the medical device industry.
- Ability to follow procedures and accurately document results
- Knowledge of site software for inventory management, Document Control and Quality incident tracking
- Good working knowledge of Excel and Microsoft Word software
- Ability to understand manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Ability to write routine reports and correspondence
- Ability to speak effectively before groups of customers or employees of an organization.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to apply mathematical concepts such as fractions, percentages, ratios, and
- proportions to practical situations
- Attention to detail
