Posted in Information Technology 6 days ago.
Type: Full Time
Job Description*Please note that this will be a typical manufacturing Swing Shift position. The employee will be working a standard 2, 2, 3 12-hour shift that will include working every other weekend.*This is 1 of 2 positions.The incumbent will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities include review of batch record pages, logbooks, equipment reports, and directly collaborating with Manufacturing Associates to assist with problem resolution. Additionally, activities include, but not limited to, the following: Data and Documentation Review and Analysis, Batch Record Review, and Deviations. This role will mirror the PF manufacturing operation in that it will follow a 12-hr/day shift schedule.Provide quality oversight during batch manufacturing.Primary point of contact for issues that need immediate corrective action plans, product impact assessments and decisions with respect to batch discrepancies.Responsible for compliance monitoring of the manufacturing area.Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.Assesses criticality of exceptions/investigations for product impact.Performs thorough reviews of the investigations and provides feedback to the department owner.Collaborates with associated departments to determine the appropriate CAPA.Responsible for controlling master production records and issuing working copies of these records according to the production scheduled.Records are printed and verified to be accurate prior to issuance.Assures compliance against applicable PRCD's providing QA controlled document creation, revision, retirement, and issuance requirements.Reviews documents for compliance and identifies gaps in existing quality systems. Initiates opportunities for process improvements.QualificationsMinimally BA/BS in Life Sciences with 1-2 years of relevant industry experience required.Attention to detail.Good organizational skills.Developing ability to multi-task and coordinate multiple activities in parallel with a sense of urgency.Ability to prioritize, plan and schedule.Strong oral and written communication skills.Investigative decision-making skills.Problem identification and resolution skills.Flexibility supporting schedule and manufacturing activities.Additional InformationThe Associate II, QA will perform QA responsibilities supporting the Quality Operations within the Biogen RTP Drug Product (DP) Parenteral Facility organization.*Please note that this will be a typical manufacturing Swing Shift position. The employee will be working a standard 2, 2, 3 12-hour shift that will include working every other weekend.PDN-92c5bc3e-6e7f-45db-bfa9-345ef94d29de