Job description

The Laboratory Quality Systems Manager is directly responsible for all areas of the Laboratory Quality System. This position is responsible for enforcing data integrity, compliance with documentation and the quality system within the laboratory. The Laboratory Quality Systems Manager is to oversee the Lab documentation work flow from start to finish. This position is responsible to ensure testing is reviewed in its entirety.

Essential Duties and Responsibilities:

• Responsible for the Laboratory procedures and documentation in regards to review of analysis, data integrity, supplier approval and executing periodic and external reference review.
• Responsible for the Laboratory portion of External Documentation Review on all products.
• Manage Compendia updates and notify for yearly subscription purchases.
• Responsible for specification generation requests, specification updates, along with the necessary documentation required for the new or updated specifications.
• Responsible for the maintenance and completion of customer audit commitments for the Laboratory portion.
• Assists with Lab Investigations, authors discrepancies, and CAPA implementation and closure for Laboratory Documentation.
• Responsible to manage the implementation and completion of Laboratory CAPA’s.
• Creates, reviews, approves and maintains all Laboratory 0documentation.
• Responsible to enforce Data Integrity Compliance, executing audit trails on instrumentation software for full analysis traceability.
• Reports all Out of Specification or Out of Trend results to the Laboratory Manager found during analysis review.
• Responsible to enforce cGMP documentation practices within the Laboratory.
• Interacts directly with Quality Systems Division to enforce the quality system in the laboratory and provide the necessary Lab documentation for regulatory submissions.
• Responsible for prioritizing the daily work load for the Laboratory Quality Systems Staff.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• Bachelor of Science degree in Science or related field and five years related experience in a quality control laboratory or cGMP laboratory
• Minimum of two years of GMP laboratory leadership experience
• Effective written and verbal communication skills, interpersonal skills and demonstrated ability to interface with production and supervisory personnel
• Ability to display sound judgement in making difficult decisions
• Knowledge and Experience with Investigations, Discrepancies, Change Control, and Corrective and Preventative Actions
• Ability to gather all pertinent data and information to make competent, timely, informed decisions with regard to problem solving and changing priorities.
• Ability to use Microsoft Excel, Word & Outlook at professional level.

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Ability to see and distinguish color
• Bend, stoop, and carry
• Repeating motion that may include wrists, hands, and fingers

Work Hours & Schedule:

The Laboratory Quality Systems Manager will be required to work a minimum of 45-50 hours per week and is a salaried position. Extenuating circumstances may require additional time for certain periods. It is widely assumed that displacement of hours and/or days will occur on recurring and non-patterned bases. This job function may include travel. This BioSpectra function may require the ability and willingness to travel to the Bangor, PA, Stroudsburg, PA, Wind Gap, PA or Rensselaer, NY Facilities.

Job Type: Full-time

Pay: From $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• On call

Ability to commute/relocate:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Microsoft Excel: 1 year (Required)
• Documentation review: 1 year (Required)

Work Location: One location

arclintfl.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, arclintfl.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, arclintfl.com is the ideal place to find your next job.