QA Specialist

Description

Daily Work Schedule: Expectations Monday to Friday 8-5 / hours arrangements if needed

Is overtime offered or required? Yes

Purpose:

• 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 Client 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. Approve MES exceptions related to production support.
• Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
• 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.
• Enter and verify batch information into the lot restriction management system.
• Assemble the batch record review package and label per the approved retention procedures.
• Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product Quality Review. Revise procedures as required.
• 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.
• Demonstrates accountability and responsibility of EHS performance and compliance.

Qualifications:

• 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)
• Excellent oral and written communication skills in English and Spanish

What are the top 3-5 skills, experience or education required for this position?

• 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 in batch record review audit process.
• Experience in the interaction with Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.
• Minimum 2 years experience

What is a nice to have (but not required) skill, experience, education, or certification?

• Experience in Batch record review

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ?

• Office majority of time – can visit production areas if needed

Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? NO

If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? NO Is Travel expected? If so, will it primarily be domestic or international? No

Is the new hire going to be working with Toxins? NO