QO Technical Associate II

Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.

Manage personal time and professional development, being accountable for results.

Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.

Identify and solve moderately routine problems.

Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.

Operate efficiently in a fast-paced, customer-oriented team environment, providing support to our Operations partners.

Complete training activities, maintain records, equipment, basic lab supplies in compliance with Current Good Manufacturing Practices (part of GxP) requirements.

Participate in laboratory investigations.

Using standardized procedures, the candidate will conduct a variety of microbiological environmental sampling in aseptic /classified processing areas. The sampling performed supports high through-put pharmaceutical manufacturing.

Within our Manufacturing facilities, provide real-time feedback/guidance within the scope of Aseptic Observations program. This includes good documentation practices, ability to manage time independently and collaborate with others within the facility to ensure compliance.

In addition to performance of routine environmental sampling, the candidate will assist in the overall operation of the microbiology laboratory including incubation of samples, read out of sample results and entry of results into an electronic database. Could second check records and assist in training others.

Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices (cGMP) impact and recommend appropriate corrective action where necessary.

Adhere to safe work practices, such as wearing appropriate personal protective equipment including lab coat, safety glasses, and gloves.

In production areas, adhere to gowning procedures and practices (i.e. aseptic gowning).

Perform equipment verification and calibration in accordance with procedures.

Maintain area and equipment in clean, safe, functional order.

Primary responsibilities are to perform environmental sampling and Aseptic Observation (real-time, direct feedback in production settings) in aseptic/classified processing areas.

This includes setting up sampling materials and data summaries in a computerized database, incubating samples, interpreting, and documenting results.

Recognize atypical data and inform supervision of relevant problems.

Enter, review, and approve data in a computerized database.

Transport samples and supplies between the laboratory and production environments.

Apply technical knowledge of microbiological principles, theories, concepts, and Pfizer processes and industry practices/standards to daily work.

Be able to work both independently and as part of a team.

Operate within established Px policies and basic colleague relations guidelines.

Contribute to the completion of specific team objectives and assigned project milestones.