Documentation Supervisor jobs in Albany, NY

QA Documentation Specialist I in Rensselaer, NY

Summary:

The QA Documentation Specialist is a quality focused individual who ensures processes conform to approved procedures and output documents are accurate. This role is responsible for maintaining the flow of controlled documents, department files and resource materials. The position is responsible for writing document control systems and putting them into action, logging, tracking and maintaining batch records, SOPs, and all documentation associated with GMP activities, coordinating document control issues between internal departments and external clients and preparing reports regarding quality issues.

We proudly offer:

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401k program
• Learning platform
• And more!

Responsibilities:

• Provide individual, team and department error/accuracy information and identify areas for improvement
• Process Standard Operating Procedures, Batch Records, Validation Documents, Miscellaneous Reports and Material Specifications through the creation and revision process, obtaining approval signatures, Mastering and distribution both internally and with clients
• Review batch record change controls and appropriate justifications, lead the change control approval process
• Verify the formatting, spelling, sentence structure, and code documentation prior to approval 
• Implement, maintain and support documentation release and change activity
• Maintain a current index of standard operating procedures and material specifications
• Ensure changes to documentation are adequately communicated to all affected parties
• Distribute and maintain reference binders for standard operating procedures and material specifications
• Review the customer feedback on executed batch records and include the changes in the master batch records 
• Maintain the master batch record tracker and lead master batch record revision process
• Review the batch record documentation per the current GMP standards and Curia procedures
• Archive GMP documents
• Maintain a chain-of-custody process for all documents that leave the archive room
• Provide general support for all document control activities
• Ability to use of computers and experienced in the use of Microsoft Office, Microsoft Access, Word, Excel and PowerPoint

Required Qualifications:

• Bachelor’s degree in relevant field
• Minimum 0-3 years’ experience in a regulated pharmaceutical or medical device environment, including 2 years’ experience with document control

Preferred Qualifications:

• Experience working with electronic document management systems

Knowledge, skills and abilities:

• Effective planning and organizational skills, with the ability to prioritize, multitask and work with a high degree of accuracy and recall 
• Exceptional written and verbal communication and presentation skills
• Ability to calculate figures and amounts
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Pay Range:

$51,000- $63,600

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; and risk of radiation and vibration. The noise level in the work environment is usually moderate.

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