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Quality Assurance Specialist
To apply for this position, submit your resume and cover letter to careers@pharmaform.com. Please include the job title in the subject line of your email. No phone calls, please.
Job Summary:
The Quality Assurance Specialist facilitates and assists in execution of systems to assure GMP compliance for all relevant operations carried out within and for PharmaForm. This function includes:
- Responsible for some aspects of the Quality Assurance Function including having an understanding of GMPs and US regulatory requirements as they apply to the manufacture, testing, release, storage and distribution of pharmaceutical products
- Responsible for supporting systems to assure GMP compliance for all relevant operations carried out, within and for PharmaForm including compliance with relevant parts of the CFR, GMPs, company policies and procedures and other established standards
Major Duties and Responsibilities:
Responsibilities include the daily execution of activities as assigned including, but not limited to, the following:
- Conducts or assists with the training of others on GMP requirements and their application
- Assists with planning, organizing and supporting a comprehensive vendor management program which includes auditing the vendors
- Assists in the materials management program, review and approval of raw material and packaging component specifications
- Provides support for manufacturing activities, such as production line clearances, production record review, and review of other manufacturing documents
- Reviews and approves analytical data
- Participates in internal audits, and assists in the resolution of internal audit findings.
- Reviews and approves Equipment/Instrument Qualifications, Calibrations and Preventive Maintenance
- Other duties as perceived and agreed upon by senior management
Important Skills and Abilities:
- Flexible in thinking and working at both a macro and micro level
- Ability to make realistic evaluations especially during the development phase
- Aptitude to draw rational conclusions based on evidence
- Capacity to analyze complex systems
- Has respect for others and works as a team
- Ability to resist pressure to deviate from established systems
- Manages personal and interpersonal stress
- Evaluates evidence in a fair and impartial manner
- Has the discipline to stay focused and complete specific tasks
- Has excellent verbal and written communication skills
- Assists in creating and maintaining an atmosphere conducive to learning, harmony and teamwork.
Machines, Tools, Equipment and Work Aids:
- Computer
- Microsoft Office software (i.e., Word, Access, Excel)
- Calculators
- Other computer programs as needed
Seriousness of Error:
Failure in job performance will have an impact on product quality and production personnel. The inability to work well with others and as a team can lead to morale problems.
Knowledge/ Education/ Work Experience:
- Minimum of one year experience within the US pharmaceutical industry or equivalent
- Has an appreciation of the regulatory framework within which the pharmaceutical industry operates
Safety & Environmental:
- The Quality Assurance Specialist is responsible for compliance with all safety regulations
- Mechanical/Electrical/Fire Hazards encountered in manufacturing and laboratory areas
- May require long periods of standing/sitting
- Dirt, dust, heat, noise, fumes, odors, vibrations encountered in manufacturing area
Contact With Others:
- Internal contact includes daily contact with all personnel of PharmaForm and regular contact with management
- External contact may require contact with clients
Exceptional Skills:
The following are examples of exceptional skills which may be used as a guide for achievement and consideration for advancement.
- Detailed attention in job performance
- Improvement on the quality system
- Good attitude, work ethic and natural leadership
- Achievement of an advanced degree or certification
- Excellent written and verbal communication
Supervision:
The Director of Quality Assurance provides overall guidance to the Quality Assurance group and delegates day to day operations.
This job description is not intended to be all-inclusive and may be amended at any time by management. This job description does not constitute a contract of employment, either expressed or implied, nor does it specify employment for a given period of time.
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