Quality Assurance; QA) Specialist

Quality Assurance (QA) Specialist I

Location:

Barceloneta, PR

Duration: 12+ months

Pay Range: $23/hr to $28.38/hr

Describes the primary goals, objective or function or outputs of this position.

The Specialist, Quality Assurance 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.

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Audit API, Bulk 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.
• Support the annual product quality review process.
• 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.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

List required and preferred qualifications up to 10). Include education, skills and experience.

• Bachelor's Degree in Science preferably in Biology, Chemistry, Biotechnology, Engineering or other related fields.
• 2 years of experience in Quality regulations and standards affecting pharmaceutical, chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
• Knowledge and experience in manufacturing of pharmaceutical or biotechnology products is needed.
• At least 1 year of 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 and communication and interpersonal skills.
• Excellent oral and written communication skills in English and Spanish are required.
• For biologics, experience in aseptic processing is preferred.

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

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

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

Daily Work Schedule Expectations:
Shift 10-6PM – Tuesday to Saturday

Candidates must be available to work any shift/weekend based on business needs.

Trainings will Monday to Friday be on 1st shift 8-4PM until certifications completion and after that will go to assigned shift.

Is overtime offered or required? Yes

Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? Onsite

How many rounds of interviews? 1 round of interview

Type of interview (video, phone or onsite)? Onsite/Presencial

Experience Level: 1-3 Years