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 |
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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 | - Maintains, operates equipment and instruments supporting reference standard processing.
- Provides general laboratory support such as routine instrument cleaning/preventative maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping
- Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
- Under close supervision, learns to troubleshoot basic instrument problems
| 20% |
Investigations | - Escalates any trends/events to the QC Lab Manager.
- Escalates any reference standard documentation issues to the QC Lab Manager.
- With guidance, participates in OOS/OOT/NOE and other investigations.
- Assists, as and when needed, scientists working in the laboratory.
- May assist in drafting, editing, and reviewing SOPs.
| 10% |
Training | - Maintains assigned training records current and in-compliance.
- May assist in the training of laboratory staff.
| 5% |
Compliance | - Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.
- Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.
- Follows internal processes related to controlled substances.
| continuous |
Safety | - Follows EH&S procedures to ensure a safe work environment.
- Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.
| continuous |
Total | 100% |
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Qualifications |
Education & Experience | Minimal acceptable level of education, work experience and certifications required for the job |
- College graduate, preferably in a Science related field
- Laboratory experience related to sample management preferred.
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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. |
- Basic knowledge of reference standard/sample management in a laboratory environment
- Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS
- Competency in Microsoft Office Suite
- Proficiency with computers
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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. |
- Ability to display and analyze data in a logical manner
- Good verbal and written communication skills as well as good computer skills
- Attention to details and accurate record keeping
- Establish and maintain cooperative working relationships with others
- Solid organizational skills
- Ability to take initiative, set priorities and follow through on assignments
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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. |
- Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
- Must occasionally lift and/or move up to 15-25 lbs.
- Ability to wear personal protective equipment, including respirators, gloves, etc.
- Specific visions abilities are required by this job include close vision and color vision
- Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods
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