Staff. QC Chemistry

Job Description

1.1. Job Title: Staff. QC Chemistry

1.2. Job Summary

Responsible for routine/non-routine QC Chemistry Laboratory analysis of finished products, process validation, Investigation, NC/CAPA. The candidate must demonstrate experience working in a cGMP laboratory and possess basic knowledge of industry regulations related to pharmaceutical and medical device manufacturing.

1.3. Essential Duties

Check, receive and register of samples, sorting samples to the test areas.

Prepare testing samples, solutions, standards and reagents to support testing.

Perform chemical analysis with compliance to the procedures and standards, with timely delivery as per sample priority or due date, without compromising the quality and accuracy.

Able to perform other testing upon completion training of test methods and Verification of Effectiveness (VOE) of QC Microbiology and QC Function Team.

Have analytical skills in the maintenance, operation and interpretation of the results obtained from analytical instruments such as the FTIR, HPLC, IR, UV, GC-MS, etc.

Support for the execution of method validations, qualifications, and transfers.

Perform routine maintenance activities in the laboratory and participates in the qualification and periodic calibration of equipment.

Able to perform review of all worksheets and logbooks.

Perform training for entry level staff and peer-to-peer training.

Identify and troubleshoot problems with instrumentation and analytical preparations.

Support and Perform Lab OOS/NC/CAPA Investigations in his/ her area.

Conduct supporting duties such as sample preparation, wash and dry apparatus and vials, and reject and discard samples.

Record any verifications, maintenance and calibration or repair works in the respective equipment logbook.

Practice 5S and conduct self-audit as per sectional audit checklist.

Maintain filing records as per record management retention schedule by filing the worksheets, shredding expired records to ensure that there are no expired records maintained.

Must be detail oriented, able to clearly record laboratory testing data and is a creative problem solver.

Follow Good Manufacturing Practices (cGMP) as well as all safety regulations and company procedures.

Adhere to all safety regulations and practices conforming to EHS regulations.

Support with Internal/External Audit such as FDA, ISO, etc.

1.4. Minimum Qualification Requirements

1.4.1. Education

Minimum College/University Degree (with basic background in science)

1.4.2. Experience

Minimum 0-1 years of experience in Laboratory operation and management.

1.4.3. Skills

Computer literate and effective communication skills (verbal, written, and listening).

Self-motivated and proactive; committed to improving lab performance, workflow, and quality.

Team player.

Able to perform the job independently.

Good planning, coordinating, managing, and time-management skills.

Able to engage with cross-functional teams and external stakeholders.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

1.5. Physical Requirements

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 25 kgs

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties

1.6. Additional Requirements

Any non-essential functions to the position and expectations such as occasional requirement to work outside normal work hours and/or travel.