Candidates should be available for any shift and Shift Rotation 7/24
Description Details
The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with policies, regulatory requirements and current Good Manufacturing Practices.
The function ensures the plant products meet specifications and quality requirements.
This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel.
The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.
Responsibilities
Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
Evaluate potential discrepancies detected in batch records and determine the need for a corrective action.
Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.
Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product
Enter and verify batch information into the lot restriction management system.
Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
Approve MES exceptions related to production support.
Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.
Prepare Certificate of Analysis, Certificates of Compliance for API and/or finished Drug Product.
Assemble the batch record review package and label per the approved retention procedures.
Quality Review. Revise procedures as required.
Demonstrates accountability and responsibility of EHS performance and compliance.
Qualifications:
List required and preferred qualifications up to 10). Include education, skills and experience.
Bachelor’s Degree in Science preferably in Biology, Chemistry, Biotechnology or Engineering Knowledge and experience in manufacturing of biotechnology products is needed and in aseptic processing is preferable.
Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)-
2 years’ Experience working in highly computerized Operations environments.
Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is necessary.
Incumbent must have excellent problem solving, analytical, communication and interpersonal skills (1 year).
Support to other Quality Areas (Validation, Compliance, SQA, among others)
Excellent oral and written communication skills in English and Spanish.
Intake Notes:
Are you open to look at candidates willing to relocate? > Note Virtual Interview process to be followed. N/A
Years of experience/education and/or certifications required:
BA, Sciences
2 years experience in audits
Pharmaceutical Experience
What are the top 3-5 skills requirements should this person have?
Audit experience
Pharmaceutical Experience
Quality Systems
Bilingual
What is a nice to have (but not required) regarding skills, requirements, experience, education,or certification?
Provide support on manufacturing area, shift rotation
What type of environment is this person working in?
Group setting
Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?
Candidates should be available for any shift and Shift Rotation 7/24
Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Onsite Role
Is the worker onshore or offshore? (If offshore confirm with manager that the worker will align to a USD Cost Center for invoicing purposes.) If no, escalate to Operations Manager N/A
Will there be Domestic and/or International Travel? NO
