Position Summary:

Our Quality Associate II will support raw material quality control by sampling incoming materials, performing routine physical and identification testing, and ensuring all results meet established specifications. Responsibilities include managing the Raw Material retain program, conducting daily instrument calibration and maintenance within a cGMP environment, and maintaining accurate, realtime laboratory documentation to support quality release and audit readiness.

This position reports to Megan Jang, Quality Assurance Mgr III and will be fully onsite Sunday- Thursday, 7 AM to 3:30 PM.

Responsibilities: Essential Duties

• Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications. -Provides support for quality investigation which includes initiation and supporting data for the resolution of quality issues.

• Provides Quality oversight over the Quality System, including but not limited to the review, reports, data (including Meta data) and records generated to support the manufacturing and distribution of product.

• Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.

• Assists in complying with regulatory requirements related to product safety and quality.

• Ensures that procedures are being followed as outlined under FDA, ICH, Standard methods and the Quality System requirements.

• Reviews records to ensure data meets the industry requirements for data integrity.

Expertise: Knowledge & Skills

• Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.

• Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.

• Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.

• May require some limited judgement in resolving problems.

• Contacts are primarily with direct supervisor, peers and subordinates.

• Ability to work non-standard schedule as needed

Required:

• High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.

• 01-02 years related experience required.

• Regular and predictable on-site attendance

Compensation: $28.41 - $30.81