Careers

Salary: $70K-$75K + Gainsharing Bonus 

Address of role: 1501 Industrial Blvd, Mainland, PA 19451

Basic Job Functions

Provide support to Quality Systems (review SOPs, protocols, reports, data, records generated and other quality-related documents) for the manufacturing and distribution of product.

Essential Functions of the Job

·       Participate in analytical laboratory investigations (LIR) and other non-conformance investigations (NIR)

·       Gather and analyze critical data from Lab Services (raw data, chromatography, calculations, data trend study) and review in LIMS

·       Review Test methods and Laboratory notebooks for accuracy

·       Analyze instrument performance, column age, previous failures

·       Gather critical data and enter onto spreadsheets

·       Conduct personnel interviews and system reviews

·       Observe analytical testing for investigations

·       Prepare investigation reports and oversee applicable approvals

·       Compile data/documentation from Manufacturing, Packaging, and/or Laboratories

·       Determine conclusions, prepare investigation reports and assign relative CAPAs

·       Summarize and complete the LIR with a scientific assignable root cause and update the LIR spread sheets in a timely manner

·       Communicate effectively with customers, project managers and  Lab Management

·       Assure timely closure of LIRs, CAPAs, assist in performing effectiveness checks

·       Review records to ensure data meets the industry requirements for data integrity - resolve any discrepancies

·       Ensure procedures are followed as outlined per FDA, ICH, Standard Methods, SOP and the Quality Systems’ requirements

·       Support Management with audits.

·       Perform other quality-related duties as assigned.

·       Maintain and Publish Monthly metrics on Laboratory investigation

Minimum Requirements of the Job

• Excellent Investigative skills such as analytical problem solving, fish bone, and root cause analysis, etc. Prior experience in Laboratory investigation is a plus.
• Ability to read, write, understand and communicate in English. Prior experience in technical writing is preferred.
• Proficient computer skills and typing
• Comfortable with working in an analytical testing laboratory atmosphere and proficient with common laboratory equipment/instrumentation, tools, reagents, etc.
• Effective analytical and problem-solving skills.  Must be able to clearly communicate technical, scientific, and regulatory information, both written and verbally
• Clear understanding of analytical testing. Familiarity of USP/EP/FCC test methods is a must
• Experience in a pharmaceutical and regulated environment
• Must have experience with Digital Documentation Management System (DMS) and LIMS
• Knowledge in operating Total Chrom and Open Lab software is desired.
• Comply with all company policies, SOPs, cGMP and relevant industry, regulatory and safety requirements
• Maintain internal training at or above 95% of assigned curriculum
• Demonstrate Good Documentation Practices
• Working knowledge of MS Office applications (Word, Excel, etc…)
• Performs all tasks with integrity. Candidate must be meticulous and organized.
• Ability to be flexible with changing priorities in a dynamic environment.
• Ability to work independently, as well as in a team, to meet deadlines as assigned.
• Candidate will be cross-trained in other Quality System functions as needed

Physical Requirements

• Good eye sight (with correction) and hearing (ability to hear alarms, ringing).
• Frequent contact with chemicals used for testing in the analytical laboratory.
• Walking/Standing/Sitting for longer periods of time
• Bending/stooping.
• Lift/carry items up to 30 pounds.
• Pushing/pulling items up to 25 pounds.
• Good eye sight (with correction) and hearing (ability to hear alarms, ringing).

Supervisory Responsibilities

No

Travel

None

Education/Experience

Quality Systems Associate/Lead Investigator-Lab Services must have earned a Bachelors of Science degree (Analytical Chemistry/Chemistry courses required), and 5+ years of Quality experience in a related field with at least a few years of hands-on lab experience.

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