Reference Standard Coordinator (QC Lab)

Job Description

Job Description

The Lab Reference Standard Coordinator, under direct supervision, performs QC laboratory reference standard receipt, processing, distribution for testing, storage and reconciliation through to disposal. Performs reference standards, chromatographic columns receipt, distribution, monitoring. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget / spend authority ( capital, operating, etc.), P&L responsibility, etc.

Typically supports one Strides business, at a single site

Key Accountabilities - key outcomes / deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Sample Management

• Performs QC reference standard / chromatographic column receipt, processing, distribution for testing and storage
• Performs QC reference standard reconciliation and disposal
• Tracks inventory of reference standards in the lab
• Uses laboratory software for reference standard, chromatographic column management
• Verifies accuracy of labeling / documentation provided with reference standards
• Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
• Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.
• Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.
• Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.
• Uses the purchasing system to procure reference standards and laboratory supplies.
• Provide status updates to QC management and other departments regarding the status of reference standard inventory.
• Maintain a safe work environment by following standards and procedures and complying with legal regulations.

65%

Lab Equipment

20%

Investigations

10%

Training

5%

Compliance

continuous

Safety

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP / GLP / GCP, Lean Manufacturing, Six-Sigma, etc.

Skills

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

Physical Requirements

Physical & mental requirements e.g., lift 40 pounds, walk across plant / warehouse, business travel (% of time), driving as part of work responsibilities, etc.