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McGuff Pharmaceuticals, Inc.
currently has an opening for a hands-on Quality Assurance Supervisor within
our Manufacturing Division located in Santa Ana, CA. This position reports
directly to the Vice President and Director of Operations.
Description/Key Responsibilities
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Responsible for
Quality activities related to our operations and coordinating Quality
Assurance and Quality Control for key sterile injectable product lines.
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Supervise QA/QC
personnel as assigned.
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Supervise the QC
unit and have responsibility and authority to approve or reject components,
in-process materials, and drug products.
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Coordinate and
conduct equipment and process qualifications and validations for targeted
products/processes.
·
Plan, direct and
perform the QA/QC functions to maintain compliance with FDA and company
standards.
·
Spearhead the
efforts of the organization in meeting applicable Quality System Regulation
requirements, specifically (but not limited to) the implementation of
internal audits, corrective and preventative actions, MRB, and training
programs.
·
Conduct internal
quality audits to identify the causes of deficiencies. Then document the
findings and ensure effective corrective action is implemented
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Lead production
monitoring activities and evaluations to determine control over applicable
variables. Perform QC inspection on products before shipment.
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Prepare periodic
presentations for management Quality System review meetings
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Perform additional
analyses as needed
Minimum Requirements:
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Bachelor's of
Science degree in a related scientific discipline (Microbiology, Chemistry
or Engineering).
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Minimum of 5 years
relevant industry experience.
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Knowledge and
understanding of cGMP's is required. Strong understanding of FDA regulation
requirements, preferably with experience dealing with FDA.
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Strong computer
skills including MS Word, Excel, Access and PowerPoint
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Excellent oral and
written communication skills.
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Excellent
interpersonal skills.
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Well organized.
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High energy,
enthusiastic self-starter who can work with minimal supervision.
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Able to lead/work
in teams as well as independently.
In addition to the minimum
requirements, the preferred candidate will have experience in the
pharmaceutical manufacturing industry (sterile fill, small volume injectable
products), direct experience in Microbiology/Chemistry laboratory methods,
strong mechanical aptitude, and experience in technical presentations and
report writing. Certifications preferred (e.g. CQE or CRE).
At McGuff Pharmaceuticals, Inc.,
we offer excellent compensation and benefits programs that reflect our goal
to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc.
provides a comprehensive benefits package that includes medical, dental, and
401K retirement plans.
Interested candidates please indicate “QA
Supervisor” on your cover letter or resume and include salary history.
Resumes without salary history will not be considered. You may either fax
your resume to 1-714-438-0520 or send via email to damon@mcguff.com. No
telephone calls please.
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