Pharma Tech Industries is seeking to hire a Chemist for the Royston, GA facility. Primary responsibilities include performing all duties necessary as a Laboratory Analyst II under the general direction of the Sr. Laboratory Manager, in the Quality Department. While performing duties, roles are flexible to improve how work is done, to streamline processes, and to meet deadlines.
Responsibilities and Duties
- Attend communication meetings and monitor daily schedule.
- Comply with dress code, safety, and departmental requirements per initial department training.
- Perform job following all safety procedures.
- Be familiar with MSDS’s for the chemicals associated with the job.
- Actively participate in department and company safety programs. Provide input and suggestions on improvements.
- Safe lifting procedure: Always use your legs to lift, not your back. Keep feet shoulder width apart, keep back slightly arched. Never twist your back to turn, use your whole body, and never shift load while carrying. If load is heavy or cumbersome, get help to lift or move.
Roles and Responsibilities:
- Ensure that all analytical testing requirements are completed following safety standards with the necessary accuracy and within the expected timeframe.
- Design and coordinate analytical special project activities for product evaluation, raw material evaluation, and process monitoring.
- Maintain Analytical files and records in accordance with GMP and company standards.
- Provide leadership in identifying areas of improvement, productivity gains, and potential problems in regards to Analytical concerns.
- Coordinate all Analytical supply purchases and equipment repair through contact with approved vendors.
- Be the true plant expert on Analytical issues.
- Conduct complex chemical and physical analyses using both instrumental and classical analytical techniques.
- Monitor and assure compliance of the laboratory to applicable company policies, procedures, compendial procedures, and current GMP regulations.
- Train designated new/existing personnel to ensure the technical competency of personnel performing analytical testing (includes OSI in Powder Analytical Lab).
- Evaluate new methods and instrumentation for feasibility/potential improvements, and make recommendations accordingly.
- Develop plans and conduct projects of investigative and analytical nature, as necessary, to solve laboratory problems, maintain and/or improve analytical support to Operations.
- Oversee the resolution of testing discrepancies and troubleshoots method and instrument problems.
- Interface with personnel form other companies/laboratories regarding testing discrepancies and method/instrument problems.
- Maintain inventory of chemicals, apparatus, and equipment for analytical laboratory and satellite laboratories.
- Analyze test data generated by self and others, utilizing statistical techniques, for presentation to management as necessary.
- Conduct complaint, validation, and inter-laboratory test method transfer sample testing according to procedures and established requirements.
- Schedule monitoring, testing, documentation and reporting of stability samples according to established procedures in a timely manner.
- Maintain the analytical lab and retain room in accordance with GMP/Plant housekeeping procedures.
- Maintain all applicable equipment and instrumentation with calibration specifications.
- Provide appropriate support to operational priorities whenever possible.
- Demonstrate effective leadership to the laboratory staff.
- Provide ideas and suggestions to improve laboratory operation.
- Effectively resolve testing discrepancies and instrument problems in a timely manner.
- Enforce the implementation of the laboratory’s safety rules.
- Initiate changes to test methods and specifications for purposes of updating, clarifying, and improving document requirements through the proper channels of approval.
- Communicate problems/situations to supervisor in a timely manner and exercises good judgment in order to follow up effectively.
- Interfaces effectively with members of QA organization, Planning, Operation, customers, etc.
- Written reports are clear, concise, timely, of high quality, and free of unaddressed issues.
- Can work with the laboratory staff to meet the desired departmental goals and objectives.
- Offers possible solutions when presenting problems to the supervisor.
- Promotes a culture of teamwork and collaboration.
- Understand physical and chemical analytical laboratory technique and specified instrumentation.
- Understand medical device/drug GMP’s, company policies, and any associated safe laboratory practices.
- Must have working knowledge of personal computers and associated software for laboratory operation.
- Must have working knowledge of pertinent company SOP’s, specifications, and document change control systems.
- Specialized knowledge and understanding of manufacturing processes and material characteristics.
- Must have a working knowledge of the contents and use of various compendia (USP/NF, EP, ASTM, etc.).
- Minimally, an associate’s degree in Chemistry or related field is preferred.
- Minimum of 2 years experience in an Analytical laboratory.
- This position will report to the Sr. Laboratory Manager.
Other Job Requirements:
- Good interpersonal skills.
- Good oral and written communication skills.
- Able to communicate with all levels in the organization.
- Projects professional, responsive and positive image.
- Detail oriented.
- Participates freely in a team environment.
- Works independently with minimal supervision.
- Key Quality issues are communicated to QA Management and other effected personnel in a timely manner.
- Fiscal responsibility.
- Zero nonconformance regarding compliance to CQA, GMP, and company policies/SOP’s.
- SOP’s and specifications in area of responsibility reflect current practice.
- Maintain and keep up to date all databases/logbooks containing analytical data.
- Complete testing responsibilities in a timely manner.
- Manage internal and external “customers” utilizing a positive, team oriented, collaborative approach, which results in the development of good departmental and cross functional relationships.
- Projects should be completed in a timely manner.
- Be proactive not reactive.
- Make suggestions to policy or procedures, which will improve service or efficiency.
- Assist other members of the QA organization without direction from management.
- Must be able to handle conflict effectively, make a stand where appropriate, and reach an agreement with business partners.
- Objective, ok to disagree; slow to criticize.
- Communicate with all levels within the organization and other outside organizations if required.
- Written documentation shall be neat, concise, and accurate.
- Working knowledge of cGMP’s and the ability to assist others to resolve compliance issues.
- Spec/TM/SOP familiarity. Working knowledge and understanding of those related to primary responsibility.
- Documentation and file requirements.
- Safety precautions in area.
The above information on this description has been designed to indicate the general functions and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of any employee assigned to this job. There will be other tasks and assignments as required to ensure maximum flexibility