SCIENTIFIC PROTEIN LABORATORIES LLC
SUPERVISOR, QC-MICROBIOLOGY/PCR
Exempt Level 8 (9:30 a.m. – 6:00 p.m.)
An opening exists for a Supervisor, QC-Microbiology/PCR in Quality Control. This person would be responsible for supervising,
coordinating and performing microbiological analyses on APIs (Active Pharmaceutical Ingredients) following strict written procedures
derived from the United States Pharmocopoeia (USP) and/or other documents, to meet strict compendial and custom specifications. This
work is performed under the cGMP/FDA (Current Good Manufacturing Practice/Food and Drug Administration) guidelines.
DUTIES AND RESPONSIBILITIES:
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Act as Designee and signing authority to laboratory management as required. As such, responsible for the continuous operation of the
lab1. Responsible for the continuous operation of the Microbiology laboratory. Must be able to facilitate the correction of any
deficiencies immediately.
Signing authority to laboratory management on raw data worksheets.
Author Standard Operating Procedures (SOPs), analytical procedures and validation protocol documentation as required. Must be
proficient in the hands-on training of all analysts and in training of the overall laboratory processes/systems and in general and complex
assays, as required. Monitor the performance of laboratory analysts in accordance with established departmental guidelines. Serve as
technical resource.
Oversee and/or prepare reagents, verify the quality documentation of those reagents and ensure that inventory levels of quality stock
reagents and standards are maintained. Correct any discrepancies immediately.
Responsible for preparation and purchase of equipment, reagents and lab supplies. Must be able to provide justifications for capital
expenses.
Ensure that staff follow 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.
Oversee the Environmental Monitoring Program (viable and non-viable particulates) of SPL’s production processes in support of
established programs. Facilitate improvements to prevent the points of microbial contamination or concerns in the processes and
implement these improvements. Ensure that documentation and final reports of improvements are in place.
Oversee and/or perform the microbiological testing, interpret the results and ensure the quality of raw material, in-process and finished
product APIs and special products.
Author and/or execute and interpret the results from microbiological experiments, analytical and instrument validation efforts as
necessary. Must be able to write reports that detail the procedures used and describe the impacts to the current operation or assay.
Ensure that all data and results are properly recorded on the appropriate documents and in electronic files. Review and interpret the
routine analytical work of other analysts. Approve all analyst data and results as required. Correct any problems that become evident.
Oversee, facilitate and perform analytical investigations for OOS (Out-of-Specification) and OOT (Out-of-Trend) microbiological data.
Assist in the gathering of evidence and results. Write summary and final reports detailing the investigation.
Ensure that the work area is maintained and in clean condition and free from clutter. Correct obstacles that hinder the cleanliness of the
laboratory. Examine all physical areas for possible improvement.
Oversee and/or perform routine calibration and preventive maintenance of laboratory equipment.
Required to cross-train analysts in QC-Chemistry into the Microbiology laboratory as necessary.
Perform other duties as assigned.
JOB STANDARDS:
Education: Minimum of a Bachelor’s Degree in Microbiology, Bacteriology or closely related scientific discipline is required. Degree
requirements may be substituted by year-for-year work experience in a directly related position. A mastery of microbiological laboratory
techniques and theories is required.
Experience: Minimum five (5) years of previous industrial microbiological laboratory experience are required or Master’s Degree in
disciplines above and three (3) years of previous industrial microbiological laboratory experience. Minimum three (3) years of Supervisory
experience preferred. Knowledge of PCR theory. Experience with Gel Electrophoresis and knowledge of QPCR preferred.
Job Standards: Demonstrated leadership 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 Microbiology laboratory.
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 attendance is required. Excellent computer skills.
Demonstrated computer experience in WORD and EXCEL is required. Experience in ACCESS and Fourth Shift is required. Effectively
translate theoretical knowledge into practical application through the work of others. Previous cGMP microbiological 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. Experience with routine and complex laboratory instrumentation (such as Colony
Counters, Incubators, Laminar Flow Hoods, Fume Hoods, pH Meters, Autoclaves, Analytical Balances and/or Conductivity Meters is
required. Familiarity with Vitek Speciation/Identification and Bactometer automated systems is desired. Aseptic technique will be required
at all times. Sterile technique is preferred. Oversee the handling of a variety of chemicals, disinfectants and raw animal tissue.
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.
Procedure for Responding to Posting:
Qualified employees who wish to be considered for this position should provide the Human Resources Department with a letter of interest
outlining applicable skills, education, and experience. Posting forms are available in Human Resources, but you may also attach a current
resume in addition to the posting form.
Please submit your information to Kathy Lynch by January 22, 2008 at 4:30 p.m. (Note: Jobs are posted for 3 working days. An employee
has an additional 2 working days to respond to a posted position.)
Date Posted: January 16, 2008
SupvMicro/PCR
Remove Posting: January 18, 2008