SCIENTIFIC PROTEIN LABORATORIES LLC
POSITION TITLE:
DEPARTMENT:
REPORTS TO:
# OF EMPLOYEES SUPERVISED:
CLASSIFICATION
Supervisor, QC – Stability & Sample Management
Quality Control (770)
Director, Quality Control
3-7
Exempt 8
PRIMARY OBJECTIVE:
The incumbent is responsible for:
 Coordinating, performing and maintaining the day-to-day operation of the Stability and QC samples
Management systems.
 Supervising, coordinating and performing analyses on APIs (Active Pharmaceutical Ingredients) following
strict written procedures derived from the United States Pharmacopoeia (USP), SPL and/or Client SOPs.
 Ensure that the stability operation is running under the cGMP/FDA (Current Good Manufacturing
Practice/Food and Drug Administration) and
ICH guidelines.
 Guarantee that all the work processes are performed timely, documented accurately and in compliance with
internal procedures and regulatory
agencies.
 Work with internal and external customers to understand deliverables and exceed customer expectations.
 Write Stability Protocols and Reports.
 Perform Trend Analysis.
 Full support of all regulatory initiatives that require Stability Data.
DUTIES AND RESPONSIBILITIES:
1. Act as Designee and signing authority to laboratory management as required. As such, responsible for the
continuous operation of the lab.
2. Responsible for the continuous operation of the QC laboratory Sample flow including in-process, release,
retain, stability and environmental monitoring samples. Must be able to facilitate the correction of any
deficiencies immediately.
3. Assists in the proper maintenance and performance of stability chambers.
4. Tracks and maintains all stability sample inventory through their testing life cycle in accordance with
established Stability Protocols and internal procedures.
5. Interfaces with various internal and external customers to ensure FDA Stability Commitments are met and
adhered to.
6. Maintains an effective system of archiving stability documentation.
7. Maintains all QC and retain sample inventory through their life cycle, to include the receipt, storage, retrieval
and destruction in accordance to internal procedures.
8. Responsible for the proper documentation and transactions associated with inventory control.
9. Signing authority to laboratory management on raw data worksheets.
10. Author Standard Operating Procedures (SOPs), analytical procedures and stability protocol documentation as
required. Monitor the performance of laboratory analysts in accordance with established departmental
guidelines.
11. Responsible for preparation and purchase of equipment, reagents and lab supplies. Must be able to provide
justifications for capital expenses.
12. Ensure that staff follows SOPs to obtain accurate results. Write/revise and serve as technical resource on
SOPs to ensure compliance with compendial documents. Ensure that laboratory analysts are in compliance
with established guidelines and procedures.
13. Perform trend analysis using statistical tools.
14. Ensure that all data and results are properly report.
15. Review and approve stability data.
16. Ensure that the work area is maintained and in clean condition and free from clutter.
17. Perform other duties as assigned within the QC operation.
JOB STANDARDS:
Education:
 Minimum of a Bachelor of Science degree (Chemistry and/or Biology) or closely related scientific discipline
is required.
Experience:
 Supervisory experience is preferred.
 Experience with statistical analysis, stability software, LIMS or any other Stability Laboratory Management
System is highly preferred.
 Minimum five (5) years in a analytical function within a pharmaceutical analytical laboratory is required or
 Master’s Degree in disciplines above and three (3) years of previous pharmaceutical laboratory experience.
 Knowledge of Stability and/or ICH guidelines a plus.
Job Standards:
A demonstrated regulatory requirement such as ICH guidelines is required. Ability to influence and motivate others
is essential. Act as a liaison for laboratory management and staff when necessary. Ability to plan and implement
guidelines to ensure proper operation of Stability program. Highly motivated individual who can demonstrate
initiative and execute and oversee actions toward improvement. Ability to work accurately with a sense of urgency,
and to be highly organized. Must be a team-oriented individual, able to communicate effectively and to work
cooperatively with others, across company and inter-company lines. Involved in company projects and committees
as required. Excellent communication skills, both written and oral are required. Excellent computer skills.
Demonstrated computer experience in WORD, EXCEL and ACCESS is required. Previous cGMP laboratory and
documentation experience is required. Strict attention to detail required. Data entry, interpretation of results,
correction and prevention of deficiencies in computer spreadsheets are required.
Work Environment: Typical Laboratory environment. PPE (Personal Protective Equipment) Required. This will
include safety glasses, laboratory coats. This may include gloves, dust masks and/or respirators. Overtime,
weekend, first and/or second shift coverage may be required.
Physical Standard: The job requires standing, sitting, walking, bending, twisting, squatting and reaching.
Frequent lifting of 1-20 lbs. and occasional lifting of 21-60 lbs. is required.
Employee Signature ________________________________________
Date______________________
Manager Signature
Date ______________________
SupvStability
01/09
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