QC Analyst Required
Samuel Walsh
Job Title : QC Analyst
Location : Myerstown, Pennsylvania 17067
Duration : 10 Months
No Of Positions : 2
Start Date : 03/15/2010
Job Description : Job Responsibilities:
• Perform standard qualitative and quantitative analysis on: purchased
raw materials, in-process products, pure drug substances and finished
pharmaceutical preparations employing accepted gravimetric and
spectrophotometer procedures, in accordance with approved testing
procedures of client, the National Formulary (NF) and the United
States Pharmacopoeia (USP).
• Utilize standard "bench" chemistry technique as well as
sophisticated electronic instrumentation, including spectrophotometer,
viscometer, etc.
• Maintain records of all analysis information of assigned products on
data sheets for permanent file and proper entry of information on
laboratory forms.
• Evaluate all data obtained from analysis; if discrepancy or
deviation occurs, consult with Supervisor and recommend additional
testing if necessary.
• Perform routine analytical and microbiological testing of raw
materials purchased from prospective suppliers to determine that the
materials meet compendia and/or company standards.
• Adhere to the pertinent aspects of Corporate and plant safety
programs and adhering to GMP’s, ISO standards or other regulations.
• Assist in investigating non-compliance investigations.
• Assist with troubleshooting analytical methodology and
instrumentation malfunctions.
• Perform special assignments as directed by supervisor.
• Assist in validation of manufacturing and production lines and
equipment pertinent to chemistry and microbiology ( e.g. equipment and
room cleaning validation).
• Perform testing of water samples from Purified (Deionized and
Reverse Osmosis) Water, USP systems.
• If assigned to Microbiology, perform microbiological environmental
monitoring in production areas and in the Microbiology Laboratory.
• If assigned to the QA Receiving area, develop specifications for
packaging components and prepare final specification sheets for new,
revised, or updated components in conjunction with packaging
departments, other client facilities and component vendors.
• If assigned to the QA Compliance area, audit all manufacturing and
packaging documentation to ensure compliance with all GMP regulations
and clients standards. Release bulk and finished package materials to
ensure timely release to meet production requirements.
• If assigned to the Compliance area, may have a MBR focus to support
conversion of paper batch documentation and creation of MBRs within
MES. This includes, but is not limited to:
o Interface with technical experts to create MBRs and convert current
records to PAS-X MBR format.
o Maintain MBR master data by capturing and analyzing process
information within the MBR - material flow, job activities, and
information flow. Maintain paper and electronic records as required.
o Revise SOPs related to use of electronic records and MBRs.
o Work with QA staff to identify process critical data prior to
creation.
o Verify created MBRs through "dry run" processes to ensure accuracy
and workability.
o Secure approval of each required document from production
departments, Process Technology department, and QA department.
o Coordinate implementation of MBRs with Production, Planning and
Inventory Control (PPIC) and production departments.
o Train employees during transition from paper batch records to MBR.
Skills Required:
• Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year
science degree required.
• Knowledge, practical application, and understanding of analytical
chemistry is necessary to perform the functions of this position; if
assigned to the QA Compliance area, knowledge of validation/QA
auditing would be equivalent experience; if assigned to Microbiology
area, microbiology experience and/or courses are preferred.
• Demonstrated capability for communicating ideas, concepts, and work
results effectively to colleagues and supervision.
• Demonstrated ability to be self-motivated as well as to work
collaboratively in a team-based environment is required.
• Must demonstrate initiative and a willingness to learn.
• Good working knowledge of advanced laboratory instrumentation and
personal computer skills are required;
• If assigned to Microbiology area, working knowledge of aseptic
techniques, environment monitoring methods, Gram staining and
microbiological test methods would be equivalent experience.
• If assigned to the QA Compliance area, working knowledge of
validation/QA auditing would be equivalent experience. If assigned
specifically to MBR role, demonstrated technical understanding of how
pharmaceutical batch records and standard operating procedures (SOPs/
GMPs) are used and organized (documentation management experience) is
required.
• Experience in wet analytical methods and instrumentation techniques
preferred; HPLC, UV, GC, IR, AA, TOC, and Dissolution preferred.
• A working knowledge of organic chemistry, statistics, data
processing and good manufacturing practices is desirable.
• A thorough understanding of National Formulary (NF); United States
Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing
procedures, as well as, US Pharmaceutical Industry Good Manufacturing
Practices (GMP’s), quality control methods and procedures preferred.
• At least 1 year of lab experience preferred:
• if assigned to the lab, bench chemistry or lab experience
preferred;
• if assigned to the QA Compliance area, previous experience in
validation and QA auditing would be preferred; If MBR role, then
automated inventory management and data collection experience is
preferred (i.e. SAP skills, LIMs skills, DCS skills, etc);
• if assigned to Microbiology area, previous experience in
microbiology processes would be preferred.
• Competencies required: analytical problem solving, alertness, work
within established policies and procedures, commitment to task,
decisiveness, effective written and interpretive communication skills,
and organization and planning skills.
MYERSTOWN QA CAREER LADDER
• Bachelor’s degree required.
• Experience in a regulatory industry or laboratory setting preferred.
To Apply please click below:
https://www.focustechnj.com/Job22.aspx
Focus Inc .
www.focustechnj.com